CHILDRENS PAIN AND FEVER DISSOLVE PACKS- acetaminophen powder

Childrens Pain and Fever by

Drug Labeling and Warnings

Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by WALGREENS CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each packet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

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 dose (see overdose warning)

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. (1-800-222-1222).

Quick 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 (see overdose warning)
• ▪ find right dose on chart. If possible, use weight to dose; otherwise, use age.
• ▪ tear packet and pour powder on your child's tongue
• ▪ repeat dose every 4 hours while symptoms last
• ▪ do not give more than 5 times in 24 hours

Weight (lb)	Age (yrs.)	Dose (packets)**
under 48	under 6 years	do not use
48-59	6-8 years	2 packets
60-71	9-10 years	2 packets
72-95	11 years	3 packets

Other information

• ▪ store at room temperature

TAMPER EVIDENT: DO NOT USE IF PACKET IS TORN OR DAMAGED

Inactive ingredients

citric acid, flavor, gelatin, isomalt, silica, sucralose

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

NDC: 0363-5101-18

Children's

Dye-Free

Pain & Fever Dissolve Packs

ACETAMINOPHEN 160 mg
PAIN RELIEVER/FEVER REDUCER

DYE FREE, ASPIRIN FREE, IBUPROFEN FREE

• No water needed
• Dissolves in seconds

AGES 6-11 YEARS

18 PACKETS*
160 mg EACH PACKET

WILD BERRY FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

*PACKETS OF POWDER

Pour powder on your child’s tongue

IMPORTANT: Keep this carton for future reference on full labeling.

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Children’s Tylenol® Dissolve Packs.

Distributed by:

WALGREEN CO.

200 WILMOT RD., CEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com © 2020 Walgreen Co.

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER  DISSOLVE PACKS
acetaminophen powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-5101
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
citric acid monohydrate (UNII: 2968PHW8QP)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
ISOMALT (UNII: S870P55O2W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE (off white)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-5101-18	18 in 1 CARTON	01/29/2020
1		1 in 1 PACKET; 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	01/29/2020

Labeler - WALGREENS CO. (008965063)