SCRC, a real company with a real product. Below is
Post# of 7769
Posted On: 03/27/2014 8:02:25 AM
SCRC, a real company with a real product. Below is information found in Daily Med Publication reviewing Pediatric RapiMeds. Notice the article is revised March 2014. Pediatric RapiMeds is just one several revenue streams Mr. Schneiderman has developed which will drive SCRC's success.
The actual packaging does not copy here. Google "DEA and ScripsAmerica" to review for yourself.
http://dailymed.nlm.nih.gov/dailymed/lookup.c...5c8f6cba1f
JUNIOR STRENGTH PAIN AND FEVER RELIEF WILD CHERRY ( acetaminophen ) tablet, chewable
[ScripsAmerica]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.c...5c8f6cba1f
Category
DEA Schedule
Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections
• Description
• Clinical Pharmacology
• Indications & Usage
• Contraindications
• Warnings
• Precautions
• Adverse Reactions
• Overdosage
• Dosage & Administration
• How Supplied
• Patient Counseling Information
• Supplemental Patient Material
• Boxed Warning
• Patient Package Insert
• Highlights
• Full Table of Contents
• Medication Guide
Active ingredient (in each tablet)
Acetaminophen 160 mg
Purpose
Pain reliever /fever reducer
Uses
? temporarily relieves minor aches and pains due to:
? the common cold
? flu
? headache
? temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
? more than 5 doses in 24 hours, which is the maximum daily amount
? with other drugs containing acetaminophen
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting , consult a doctor promptly.
Do not use
? with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
? if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if your child has
liver disease.
Ask a doctor or pharmacist before use if your child is
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
Stop use and ask a doctor if
? pain gets worse or lasts more than 5 days
? fever gets worse or lasts more than 3 days
? new symptoms occur
? redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
? do not give more than directed
(see overdose warning)
? this product does not contain directions or complete warnings for adult use
? find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
? dissolve in mouth or chew before swallowing
? if needed, repeat dose every 4 hours while symptoms last
? do not give more than 5 times in 24 hours
? do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Tablets*
Under 48 Under 6 Ask a doctor
48-59 6-8 2
60-71 9-10 2 1/2
72-95 11 3
*or as directed by a doctor
Other information
? TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
? store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
? avoid high humidity
? see end flap for expiration date and lot number
Inactive ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, stearic acid, sucralose
Questions or comments?
Call 1-800-957-7622
Product Packaging
RapiMed™
Melts in Your Child"s Mouth
NDC 51208-003-24
Junior Strength
For Children Ages 6-11
Pain &
Fever Relief
ACETAMINOPHEN - 160 mg each
• Pain Reliever/Fever Reducer
• Contains no Aspirin
• Melts in Your Child's Mouth
24 Quick Dissolving Tablets
WILD CHERRY FLAVOR
50844 ORG111364408
Manufactured in the United States of America
Distributed by: Scrips America Inc.
Tyson Corner, VA 22102
Telephone: 1-800-596-4874
Website: www.rapidmeds.com
Email: wecare@rapidmeds.com
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Scrips America 44-644
JUNIOR STRENGTH PAIN AND FEVER RELIEF WILD CHERRY
acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51208-003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
CROSPOVIDONE
D&C RED NO. 27
D&C RED NO. 30
DEXTROSE
ETHYLCELLULOSES
MAGNESIUM STEARATE
MANNITOL
STEARIC ACID
SUCRALOSE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 16mm
Flavor BUBBLE GUM Imprint Code 44;644
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51208-003-24 1 in 1 CARTON
1 24 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 02/25/2005
Labeler - ScripsAmerica (842014177)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(51208-003)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(51208-003)
Revised: 3/2014
ScripsAmerica
Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services
The actual packaging does not copy here. Google "DEA and ScripsAmerica" to review for yourself.
http://dailymed.nlm.nih.gov/dailymed/lookup.c...5c8f6cba1f
JUNIOR STRENGTH PAIN AND FEVER RELIEF WILD CHERRY ( acetaminophen ) tablet, chewable
[ScripsAmerica]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.c...5c8f6cba1f
Category
DEA Schedule
Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections
• Description
• Clinical Pharmacology
• Indications & Usage
• Contraindications
• Warnings
• Precautions
• Adverse Reactions
• Overdosage
• Dosage & Administration
• How Supplied
• Patient Counseling Information
• Supplemental Patient Material
• Boxed Warning
• Patient Package Insert
• Highlights
• Full Table of Contents
• Medication Guide
Active ingredient (in each tablet)
Acetaminophen 160 mg
Purpose
Pain reliever /fever reducer
Uses
? temporarily relieves minor aches and pains due to:
? the common cold
? flu
? headache
? temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
? more than 5 doses in 24 hours, which is the maximum daily amount
? with other drugs containing acetaminophen
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting , consult a doctor promptly.
Do not use
? with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
? if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if your child has
liver disease.
Ask a doctor or pharmacist before use if your child is
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
Stop use and ask a doctor if
? pain gets worse or lasts more than 5 days
? fever gets worse or lasts more than 3 days
? new symptoms occur
? redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
? do not give more than directed
(see overdose warning)
? this product does not contain directions or complete warnings for adult use
? find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
? dissolve in mouth or chew before swallowing
? if needed, repeat dose every 4 hours while symptoms last
? do not give more than 5 times in 24 hours
? do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Tablets*
Under 48 Under 6 Ask a doctor
48-59 6-8 2
60-71 9-10 2 1/2
72-95 11 3
*or as directed by a doctor
Other information
? TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
? store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
? avoid high humidity
? see end flap for expiration date and lot number
Inactive ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, stearic acid, sucralose
Questions or comments?
Call 1-800-957-7622
Product Packaging
RapiMed™
Melts in Your Child"s Mouth
NDC 51208-003-24
Junior Strength
For Children Ages 6-11
Pain &
Fever Relief
ACETAMINOPHEN - 160 mg each
• Pain Reliever/Fever Reducer
• Contains no Aspirin
• Melts in Your Child's Mouth
24 Quick Dissolving Tablets
WILD CHERRY FLAVOR
50844 ORG111364408
Manufactured in the United States of America
Distributed by: Scrips America Inc.
Tyson Corner, VA 22102
Telephone: 1-800-596-4874
Website: www.rapidmeds.com
Email: wecare@rapidmeds.com
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Scrips America 44-644
JUNIOR STRENGTH PAIN AND FEVER RELIEF WILD CHERRY
acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51208-003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
CROSPOVIDONE
D&C RED NO. 27
D&C RED NO. 30
DEXTROSE
ETHYLCELLULOSES
MAGNESIUM STEARATE
MANNITOL
STEARIC ACID
SUCRALOSE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 16mm
Flavor BUBBLE GUM Imprint Code 44;644
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51208-003-24 1 in 1 CARTON
1 24 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 02/25/2005
Labeler - ScripsAmerica (842014177)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(51208-003)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(51208-003)
Revised: 3/2014
ScripsAmerica
Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services
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(0)ScripsAmerica Inc (SCRC) Stock Research Links
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