Pain Relief Childrens: Package Insert and Label Information

PAIN RELIEF CHILDRENS- acetaminophen tablet, chewable
Amerisource Bergen

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.

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • sore throat
  • flu
  • toothache
  • the common cold
• 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.

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• 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 (chewable tablets)*
Under 24	Under 2	Ask a doctor
24-35	2-3	1 tablet
36-47	4-5	1 1/2 tablets
48-59	6-8	2 tablets
60-71	9-10	2 1/2 tablets
72-95	11	3 tablets

*or as directed by a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• avoid high humidity
• store at 25°C (77°F); 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, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

GOOD
NEIGHBOR
PHARMACY®

Compare to Children’s Tylenol^® active ingredient**

NDC 46122-424-62

For Ages 2-11

CHILDREN’S

Pain Relief
acetaminophen 160 mg
chewable tablets

Pain Reliever/Fever Reducer

•aspirin free •ibuprofen free

Bubblegum Flavor

Chew or crush tablets completely before swallowing.
Do not swallow tablets whole.

24 Chewable Tablets | 160 mg Each Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

**This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of
the registered trademark Children’s Tylenol^®.
50844 REV0522B45008

GOOD NEIGHBOR PHARMACY BRAND PRODUCTS
SATISFACTION GUARANTEED

Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

Good Neighbor Pharmacy 44-450

PAIN RELIEF CHILDRENS acetaminophen tablet, chewable

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-424 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE CROSPOVIDONE D&C RED NO. 27 ALUMINUM LAKE D&C RED NO. 30 DEXTROSE MONOHYDRATE ETHYLCELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL HIGH DENSITY POLYETHYLENE STEARIC ACID SUCRALOSE

Product Characteristics Color pink Score 2 pieces Shape ROUND Size 16mm Flavor BUBBLE GUM Imprint Code 44;450 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:46122-424-62 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (46122-424-62)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/25/2005

Labeler — Amerisource Bergen (007914906)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	pack (46122-424)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	manufacture (46122-424), pack (46122-424)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867894	manufacture (46122-424)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	pack (46122-424)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		117025878	manufacture (46122-424)

Revised: 07/2022 Amerisource Bergen