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ACETAMINOPHEN 80 MG FRUIT CHEW

Medically reviewed on January 1, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 80mg
Labeler: Proficient Rx LP
NDC Code: 63187-944

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.

ACETAMINOPHEN USP 80 MG FRUIT CHEW TABLET

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP, 80 mg

Purposes

Pain Reliever/Fever Reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

headache
the common cold
flu
toothache
sore throat

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include :

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, lasts for more than 2 days or 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 wheater a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the child has liver disease

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

Drug Facts continued on back of label

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
redness or swelling is present
any new symptoms appear

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. 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 take more than directed (see Overdose warning)
find correct dose on chart below
if possible, use weight to dose, otherwise use age
chew tablets before swallowing
give dose every 4 hours while symptoms last
do not give more than 5 doses in 24 hours

Weight (pounds)

Age (years)

Dose (tablets)

72-95

11-12

4-6

60-71

9-10

4-5

48-59

6-8

4

36-47

4-5

3

24-35

2-3

2

under 24

under 2

ask a doctor

Other information
Phenylketonurics: each tablet contains: phenylalanine 5 mg

Other information
store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

aspartame, compressible sugar, D&C red #27 (Al-lake), dextrose, FD&C yellow #6 (Al-lake), flavors, magnesium stearate, microcrystalline cellulose, stearic acid

Questions or comments?

call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

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

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

NDC 63187-944-30

FRUIT FLAVORED

Acetominophen USP 80 mg

PAIN RELIEVER

FEVER REDUCER

30 CHEWABLE TABLETS

*Compare to Active Ingredient in Children's TYLENOL®

ACETAMINOPHEN 80 MG FRUIT CHEW 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-944(NDC:69618-012)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
D&C RED NO. 27 
STEARIC ACID 
DEXTROSE, UNSPECIFIED FORM 
SUCROSE 
Product Characteristics
Colorpink (Light Pink) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeAP;051
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-944-2020 TABLET in 1 BOTTLE, PLASTIC
2NDC:63187-944-3030 TABLET in 1 BOTTLE, PLASTIC
3NDC:63187-944-4040 TABLET in 1 BOTTLE, PLASTIC
4NDC:63187-944-5050 TABLET in 1 BOTTLE, PLASTIC
5NDC:63187-944-6060 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2015
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-944), RELABEL(63187-944)

 
Proficient Rx LP

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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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