Pain and Fever Relief by ScripsAmerica / LNK International, Inc. RapiMed 44-449

Drug Details [pdf]

PAIN AND FEVER RELIEF JUNIOR STRENGTH/WILD GRAPE FLAVOR- acetaminophen tablet, chewable
ScripsAmerica

Disclaimer: 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.

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RapiMed 44-449

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
- sore throat
- 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

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

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)
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, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

call 1-800-957-7622

Principal Display Panel

RapiMed™
Melts in Your Child's Mouth

NDC: 51208-004-24

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 GRAPE FLAVOR

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

50844 ORG021344908

Distributed by: Scrips America Inc.

Tysons Corner, VA 22102
Telephone: 1-800-596-4874
Website: www.rapimeds.com
Email: wecare@rapimeds.com

Manufactured in the United States of America

RapiMed 44-449

PAIN AND FEVER RELIEF JUNIOR STRENGTH/WILD GRAPE FLAVOR
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51208-004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)

Product Characteristics
Color	PURPLE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	GRAPE	Imprint Code	44;449
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 51208-004-24	4 in 1 CARTON	01/28/2005	12/20/2019
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	01/28/2005	12/20/2019

Labeler - ScripsAmerica (842014177)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(51208-004)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(51208-004)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(51208-004)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(51208-004)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(51208-004)

Revised: 12/2019

Document Id: e1a7a999-afb0-4d05-b695-e51691a4a06d

Set id: 023a9969-8a41-4790-a686-d5bd37902a4e

Version: 9

Effective Time: 20191220

ScripsAmerica