CHILDRENS PAIN AND FEVER- acetaminophen suspension

Childrens Pain and Fever by

Drug Labeling and Warnings

Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. 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	under 2 years	Ask a doctor
24-35	2-3 years	5 mL
36-47	4-5 years	7.5 mL
48-59	6-8 years	10 mL
60-71	9-10 years	12.5 mL
72-95	11 years	15 mL

*or as directed by a doctor

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 20° to 25°C (68° to 77°F)
• do not use if printed neckband is broken or missing

Inactive ingredients

acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or comments?

Call 1-800-845-8210.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

v-38612

PRINCIPAL DISPLAY PANEL

NDC: 51316-781-04

Children's Pain & Fever

Acetaminophen

(160 mg / 5 mL)

Pain Reliever; Fever Reducer

Ages 2 to 11 years

Free of: Alcohol, Aspirin, Ibuprofen & Gluten

Strawberry Flavor

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-781
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-781-04	1 in 1 CARTON	03/24/2023	05/31/2025
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/24/2023	05/31/2025

Labeler - CVS Pharmacy (062312574)