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Premier Value Childrens Acetaminophen Melts

Medically reviewed on January 16, 2018.

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg
Labeler: Chain Drug Consortium
NDC Code: 68016-196

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.

Premier Value Children’s Pain Reliever

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses
temporarily relieves minor aches and pains due to:
the common cold
headache
flu
sore throat
toothache
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 right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
find the right dose on chart. 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 years

 ask a doctor

 24-35

 2-3 years

 2 tablets

 36-47

 4-5 years

 3 tablets

 48-59

 6-8 years

 4 tablets

 60-71

 9-10 years years

 5 tablets

 72-95

 11

 6 tablets

Other information
store at controlled room temperature 20-25ºC (68-77ºF). 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 30 aluminum lake, dextrose, ethylcellulose, FD&C blue 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose

Questions or comments?

1-866-467-2748

Product Packaging

NDC 68016-196-00

Compare to Children's Tylenol® Meltaways® Active Ingredient*

Premier Value

Children's
Pain Reliever

Ages 2-6


ACETAMINOPHEN

pain reliever/fever reducer
Aspirin Free/ Ibuprofen Free

GRAPE FLAVOR

30 count – 80mg each

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.

PREMIER VALUE CHILDRENS ACETAMINOPHEN MELTS 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-196
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
STARCH, CORN 
CROSPOVIDONE (15 MPA.S AT 5%) 
D&C RED NO. 30 
DEXTROSE, UNSPECIFIED FORM 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
GELATIN 
MALTODEXTRIN 
MAGNESIUM STEARATE 
SUCRALOSE 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint CodeRP080
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-196-001 BOTTLE, PLASTIC in 1 CARTON
130 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/06/2004
Labeler - Chain Drug Consortium (101668460)

 
Chain Drug Consortium

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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