PAIN AND FEVER CHILDRENS- acetaminophen tablet, chewable

Pain and Fever by

Drug Labeling and Warnings

Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

Walgreens

NDC: 0363-4501-08

Compare to Children's Tylenol® active ingredient††

children's
Pain & Fever

ACETAMINOPHEN 160 mg
CHEWABLE TABLETS
PAIN RELIEVER / FEVER REDUCER

CHEWABLE
ASPIRIN FREE
IBUPROFEN FREE

BUBBLEGUM FLAVOR
Actual Size

24 TABLETS
(160 mg each)
SEE NEW DOSING DIRECTIONS

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

AGES
2-11
YEARS

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

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Tylenol®.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2018 Walgreen Co.

50844    REV1018C45008

Walgreens 44-450

INGREDIENTS AND APPEARANCE

PAIN AND FEVER  CHILDRENS
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-4501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 30 (UNII: 2S42T2808B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-4501-08	4 in 1 CARTON	02/25/2005
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/25/2005

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-4501)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0363-4501)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0363-4501)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0363-4501)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0363-4501)