ACETAMINOPHEN 80 MG FRUIT CHEW- acetaminophen tablet
A-S Medication Solutions

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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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

Warnings

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

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

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

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

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

Other information

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

www.reliable1labs.com

HOW SUPPLIED

Product: 50090-3162

NDC: 50090-3162-0 30 TABLET in a BOTTLE, PLASTIC

ACETAMINOPHEN

Label Image
ACETAMINOPHEN 80 MG FRUIT CHEW
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-3162(NDC:69618-012)
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
ASPARTAME (UNII: Z0H242BBR1)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
SUCROSE (UNII: C151H8M554)
Product Characteristics
Color pink (Light Pink) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code AP;051
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-3162-0 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/10/2017
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 11/01/2015
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-3162)

Revised: 6/2018
Document Id: 3c5df3f7-1888-4584-b1fe-e4adfa7c4e76
Set id: 62d25c2b-911c-461d-b834-241632ca8e8b
Version: 1
Effective Time: 20180626
A-S Medication Solutions