FDA.reportPublic FDA data

Firstcare Children's Pain + Fever Acetaminophen 80 mg Chewable Tablets

Manufacturer
USpharma Ltd
Effective date
2026-03-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-17 21:45:43

Label at a glance#

ProductFirstCare Childrens Pain Fever Acetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) Instruct child to chew each piece thoroughly before swallowing find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours  Weight (lbs.) Age (yrs.) Dose (chewable tablet)* U...

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 80 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Liver warning:thisproduct 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

OTC - DO NOT USE SECTION

  •  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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child hasliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • Instruct child to chew each piece thoroughly before swallowing
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours 

Weight (lbs.)

Age (yrs.)

Dose (chewable tablet)*

Under 24

Under 2 years

Ask a doctor

24-35

2-3 years

2 chewable tablets

36-47

4-5 years

3 chewable tablets

48-59

6-8 years

4 chewable tablets

60-71

9-10 years

5 chewable tablets

72-95

11 years

6 chewable tablets

* or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each chewable tablet contains:calcium 5 mg, magnesium 5 mg, potassium 10 mg, sodium 5 mg.

      low sodium

  • Store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container;do not use if printed seal under cap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavors, corn syrup, D&C red no. 33, geleol mono and diglycerides, hydroxypropyl betadex, maltodextrin, monobasic potassium phosphate, pregelatinized starch, purified water, seaweed extract (carrageenan), sodium chloride, stevia sweetener, sucralose, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-227-6151

Principal Display Panel - Firstcare Children's Pain + Fever Acetaminophen 80 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71594-702-13

FIRSTCARE

CHILDREN'S

Pain + Fever

ACETAMINOPHEN 80 mg

Pain Reliever

Fever Reducer

24 Chewable               Cherry Flavor

Tablets

Principal Display Panel-FirstCare Acetaminophen 80 mgPrincipal Display Panel-FirstCare Acetaminophen 80 mg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71594-70271594-702-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
GLYCERYL MONO AND DIPALMITOSTEARATEKC98RO82HJIACT
SUCRALOSE96K6UQ3ZD4IACT
STEVIA LEAF6TC6NN0876IACT
SODIUM CHLORIDE451W47IQ8XIACT
CARRAGEENAN5C69YCD2YJIACT
MALTODEXTRIN7CVR7L4A2DIACT
MONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51IACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT
CORN SYRUP9G5L16BK6NIACT
D&C RED NO. 339DBA0SBB0LIACT
STARCH, CORNO8232NY3SJIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-03-23full-release2026-06-01 01:51:08

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
FirstCare Childrens Pain Fever AcetaminophenACETAMINOPHEN 80 MGUSpharma Ltd9fc05ba6-5667-457e-82c1-a8b4e16cadda2026-03-23WarningsExact identifier
ndc (package): 71594-702-13
ndc (product): 71594-702
ndc11 (package): 71594070213
spl id: 4db0ae88-b364-2877-e063-6394a90a8383
spl set id: 9fc05ba6-5667-457e-82c1-a8b4e16cadda

Reported adverse events (FAERS/openFDA)#

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