Pain Relief Childrens: Package Insert and Label Information

PAIN RELIEF CHILDRENS- acetaminophen tablet, chewable
Rite Aid Corporation

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

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • 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

NDC 11822-4450-8

Compare to the active ingredient in Children’s Tylenol ®**

FOR AGES 2-11 YEARS

CHILDREN’S PAIN RELIEF ACETAMINOPHEN

ACETAMINOPHEN 160mg CHEWABLE TABLETS

PAIN RELIEVER/FEVER REDUCER

contains no aspirin or ibuprofen

chew or crush tablets completely
before swallowing.

ACTUAL SIZE

BUBBLE GUM
FLAVOR

24
CHEWABLE TABLETS

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

**This product is not manufactured or distributed by Johnson
& Johnson Corporation, owner of the registered trademark
Children’s Tylenol®. 50844 REV0522C45008

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011
www.riteaid.com

SATISFACTION
GUARANTEE

If you’re not satisfied, we’llhappily refund your money.

Rite Aid 44-450
(click image for full-size original)

Rite Aid 44-450

PAIN RELIEF CHILDRENS acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-4450
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, UNSPECIFIED
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:11822-4450-8 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (11822-4450-8)
2 NDC:11822-4450-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 2 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11822-4450-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 02/25/2005
Labeler — Rite Aid Corporation (014578892)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (11822-4450)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (11822-4450), pack (11822-4450)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (11822-4450)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (11822-4450)

Revised: 05/2023 Rite Aid Corporation

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