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

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]

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.

----------

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


RapidMed 44-449

RapiMed 44-449

PAIN AND FEVER RELIEF  JUNIOR STRENGTH/WILD GRAPE FLAVOR
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51208-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51208-004-244 in 1 CARTON01/28/200512/20/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/28/200512/20/2019
Labeler - ScripsAmerica (842014177)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(51208-004)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(51208-004)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(51208-004)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(51208-004)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(51208-004)

Revised: 12/2019
 
ScripsAmerica