Apap Child 160mg/5ml

Apap Child 160mg/5ml
SPL v1
SPL
SPL Set ID 42a17f54-7851-84fb-e063-6394a90a9ec1
Route
ORAL
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-01
Description

Active ingredient (per 5 mL teaspoonful) Acetaminophen 160 mg

Medication Information

Warnings and Precautions

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 thoat 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 acetaminophe or any of the inactive indreadients in this product.

Ask a doctor before use if your child hasliver disease.

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

When using this product: Do not exceed recommended dose.

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.
Indications and Usage

Uses

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

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • dosage may be repeasted every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
Weight (lbs) under 24 24-35 36-47 48-59 60-71 72-95
Age (years) under 2 2 to 3 4 to 5 6 to 8 9 to 10 11
Dosage Teaspoonful (tsp) consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL)

Description

Active ingredient (per 5 mL teaspoonful) Acetaminophen 160 mg

Section 43683-2

Changed Uses to:

temporarily relieves minor aches and pains due to

  • headache
  • toothache
  • the common cold
  • temporarily reduces fever
  • flu
  • sore throat

Removed 12 years to adult from dosage

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Purpose

Pain Reliever/Fever Reducer

Section 55106-9

Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • the common cold
  • temporarily reduces fever
  • flu
  • sore throat
Dosage and Administration (34068-7)

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • dosage may be repeasted every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
Weight (lbs) under 24 24-35 36-47 48-59 60-71 72-95
Age (years) under 2 2 to 3 4 to 5 6 to 8 9 to 10 11
Dosage Teaspoonful (tsp) consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL)

Warnings and Precautions (34071-1)

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 thoat 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 acetaminophe or any of the inactive indreadients in this product.

Ask a doctor before use if your child hasliver disease.

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

When using this product: Do not exceed recommended dose.

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.
Section 43683-2 (43683-2)

Changed Uses to:

temporarily relieves minor aches and pains due to

  • headache
  • toothache
  • the common cold
  • temporarily reduces fever
  • flu
  • sore throat

Removed 12 years to adult from dosage

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Purpose

Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:30.829880 · Updated: 2026-03-14T23:11:04.312793