FIRSTCARE CHILDRENS PAIN FEVER ACETAMINOPHEN- acetaminophen 80 mg tablet, chewable

FirstCare Childrens Pain Fever Acetaminophen by

Drug Labeling and Warnings

FirstCare Childrens Pain Fever Acetaminophen by is a Otc medication manufactured, distributed, or labeled by USpharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

•  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 hasliver disease

Ask a doctor or pharmacist before use if your child istaking 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)
• 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

• 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

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?

Call 1-800-227-6151

SPL UNCLASSIFIED SECTION

Patents: www.uspharmaltd.com/patent

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

NDC: 71594-702-13

FIRSTCARE

CHILDREN'S

Pain + Fever

ACETAMINOPHEN 80 mg

Pain Reliever

Fever Reducer

24 Chewable               Cherry Flavor

Tablets

INGREDIENTS AND APPEARANCE

FIRSTCARE CHILDRENS PAIN FEVER ACETAMINOPHEN 
acetaminophen 80 mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71594-702
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STEVIA LEAF (UNII: 6TC6NN0876)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71594-702-13	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/23/2026

Labeler - USpharma Ltd (080664601)

Registrant - USpharma Ltd (080664601)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(71594-702) , pack(71594-702)