PAIN AND FEVER RELIEF CHILDRENS STRENGTH- acetaminophen tablet, chewable

Pain and Fever Relief by

Drug Labeling and Warnings

Pain and Fever Relief by is a Otc medication manufactured, distributed, or labeled by ScripsAmerica, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • flu
  • sore throat
  • toothache
  • the common cold
• 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

• if your child is allergic to acetaminophen or any of the inactive ingredients in this product
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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.
• chew before swallowing; this product will soften in mouth for ease of chewing
• 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)	Dose (tablets)*
Under 24	Under 2	Ask a doctor
24-35	2-3	2
36-47	4-5	3
48-59	6-8	4
60-71	9-10	5
72-95	11	6

*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 15º-30ºC (59º-86ºF)
• avoid high humidity
• protect from light
• see end flap for expiration date and lot number

Inactive ingredients

citric acid, corn starch, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, 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: 51208-001-30

Children's Strength
For Children Ages 2-6

Pain &
Fever Relief
ACETAMINOPHEN-80 mg each

Pain Reliever/Fever Reducer
Contains no Aspirin
Melts in Your Child's Mouth

30 Quick Dissolving Tablets

WILD CHERRY FLAVOR

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

Manufactured
in the United
States of America

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

50844    ORG111364301

Scrips America 44-643

INGREDIENTS AND APPEARANCE

PAIN AND FEVER RELIEF  CHILDRENS STRENGTH
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51208-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	13mm
Flavor	CHERRY (Wild Cherry)	Imprint Code	44;643
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51208-001-30	5 in 1 CARTON	03/18/2014	06/02/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	03/18/2014	06/02/2020

Labeler - ScripsAmerica (842014177)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(51208-001)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(51208-001)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(51208-001)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(51208-001)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(51208-001)