CHILDRENS CHEWABLE ACETAMINOPHEN- acetaminophen tablet, chewable

Childrens Chewable Acetaminophen by

Drug Labeling and Warnings

Childrens Chewable Acetaminophen by is a Otc medication manufactured, distributed, or labeled by BLESSINGS INTERNATIONAL, Geri-Care Pharmaceutical Corp. 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
• 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

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.

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.

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: 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

Chew tablets thoroughly before swallowing.
This product does not contain directions or complete warnings for adults.
Follow dosage on table or use as doctor directs. If possible
use weight to dose; otherwise use age. Give every 4 hours
as needed; do not give more than 5 doses in 24 hours.
Administer only under adult supervision.
DO NOT EXCEED DOSE SHOWN. See Overdose Warning.

Weight (lbs)	Under 24	24-35	36-47	48-59	60-71	72-95
Age	Under 2	2-3	4-5	6-8	9-10	11
Tablets	Ask Doctor	2	3	4	5	6

Other information

• TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
• store at 20°C-25°C (68°F-77°F); avoid high humidity
• Keep tightly closed
• Phenylketonurics: contains phenylalanine 5mg per tablet.

Inactive ingredients

Aspartame (contains phenylalanine), cellulose, D&C Red #27, Dextrose, FD&C Yellow #6, fruit flavor,
magnesium stearate, Prosweet, stearic acid, sugar.

Principal display panel

INGREDIENTS AND APPEARANCE

CHILDRENS CHEWABLE ACETAMINOPHEN 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51376-130
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)
INVERT SUGAR (UNII: ED959S6ACY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink (light)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor	FRUIT	Imprint Code	AP;051
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51376-130-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/01/2022

Labeler - BLESSINGS INTERNATIONAL (064965742)

Registrant - Geri-Care Pharmaceutical Corp (611196254)