Childrens Pain and Fever

Manufacturer
AptaPharma Inc.
Effective date
2021-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:45:13

Label at a glance#

ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient
(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child Is
taking the blood thinning drug warfarin.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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 INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, butylparaben,

D&C # 33, FD&C Blue#1, flavor, glycerin, high fructose

corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol, purified water,

sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

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

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS​

Health®

Compare to the active

ingredient in Children's

Tylenol​®​ Oral Suspension**

Fever Reducer/ Pain Reliever

Children's Pain and Fever

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Asprin Free

For ages 2 to 11

GRAPE FLAVOR

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-126

Carton

328-26328-26

Bottle

328 Botl Grape328 Botl Grape

res

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-32876281-328-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
962739eb-33c7-4eb5-9799-a9d680239751ec28fea7-e4f0-45c3-8159-7756351f88f12023-12-30WarningsExact identifier
spl set id: ec28fea7-e4f0-45c3-8159-7756351f88f1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.