CVS Health Children's Pain & Fever Acetaminophen

Childrens Pain and Fever by

Drug Labeling and Warnings

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

Drug Details [pdf]

CHILDRENS PAIN AND FEVER- acetaminophen suspension 
AptaPharma Inc.

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CVS Health Children's Pain & Fever Acetaminophen

Drug Facts

Active ingredient
(in each 5 mL = 1 teaspoonful)

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 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
adrug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the
inactive ingredlents 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 worseor 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.

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

Taking more than the recommended dose (overdose) may can
liver damage. 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 children
even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use.
• shake well before using
• mL = milliter; tsp = teaspoon
• find right dose on chart below. If possible, use weight to dose; otherwise , use age.
• if needed, 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 (mL or tsp)*
under 24	under 2 years	ask a doctor
24 - 35	2 - 3 years	5 mL (1 tsp)
36 - 47	4 - 5 years	7.5 mL (1 1/2 tsp)
48 - 59	6 - 8 years	10 mL (2 tsp)
60 - 71	9 - 10 years	12.5 mL ( 2 1/2 tsp)
72 - 95	11 years	15 mL (3 tsp)

* 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 (1 tsp) contains: sodium 3 mg
• store between 20°-25°C (68°-77°F)
• do not refrigerate
• Keep carton for full directions for use

Inactive ingredients anhydrous citric acid, butylparaben,
FD&C red #40, flavor, glycerin, high fructose corn syrup,
microcrystalline cellulose and carboxymethylcellulose sodium,
propylene giycol, purified water, sodium benzoate, sorbitol solution,
sucralose, xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Package Labeling

CVS

Health®

Compare to the active

ingredient in Children's

Tylenol® Oral Suspension**

Suspension Liquid

NDC: 76281-327-26

Children's Pain &

Fever

ACETAMINOPHEN

160 mg / 5 mL

Pain reliever;

Fever reducer

For ages 2 to

11 years

Free of:

• Added alcohol
• Aspirin
• Ibuprofen

CHERRY FLAVOR

Use ONLY Enclosed Dosing Cup

8 FL OZ (237 mL)

**This product is not manufactured or distrubuted

by McNeil Consumer Healthcare, distributor of

Children's Tylenol® Oral Suspension.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-37464

                                                BX-125

DO NOT USE IF PRINTED NECK BAND IS

BROKEN OR MISSING

res

CHILDRENS PAIN AND FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-327
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)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
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: 76281-327-26	1 in 1 CARTON	05/04/2021
1		237 mL in 1 BOTTLE; 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	05/04/2021	12/30/2023

Labeler - AptaPharma Inc. (790523323)

Revised: 12/2023

Document Id: 37e1514b-a99f-4831-a944-20efb6d7de8f

34390-5

Set id: 2c04ef82-6297-4f4a-a2d5-4f6016a52c40

Version: 2

Effective Time: 20231230