WALGREEN CHILDRENS PAIN PLUS FEVER- acetaminophen suspension

Walgreen Childrens Pain plus Fever by

Drug Labeling and Warnings

Walgreen Childrens Pain plus 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 5 mL)

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)
• ▪ shake well before using
• ▪ mL = milliliter
• ▪ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• ▪ remove the child protective cap and squeeze your child's dose into the dosing cup
• ▪ repeat dose every 4 hours while symptoms last
• ▪ do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL) **
under 24 lbs	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• ▪ each 5 mL contains: sodium 2 mg
• ▪ store at room temperature

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Children’s Tylenol® Dye-Free Oral Suspension*

NDC: 0363-6958-08

Children’s

Pain+Fever

Relief

Acetaminophen
Oral Suspension

Pain Reliever-Fever Reducer

• Dye-Free
• No Added Alcohol
• Sugar Free

For Ages 2-11 Years

Cherry Flavor
Naturally Flavored

8 FL. OZ. (240 mL)
160 mg per 5 mL

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol® Dye-Free Oral Suspension.

Distributed By:

Package Label for 8 FL OZ (240 mL)

Package Label for 16 FL OZ (480 mL)

INGREDIENTS AND APPEARANCE

WALGREEN CHILDRENS PAIN PLUS FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6958
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6958-08	1 in 1 PACKAGE	02/24/2023
1		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0363-6958-16	2 in 1 PACKAGE	02/24/2023
2		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/24/2023

Labeler - WALGREENS CO. (008965063)