Childrens Acetaminophen Oral Suspension

Childrens Acetaminophen Oral Suspension
SPL v2
SPL
SPL Set ID 8231dd91-e9e6-4350-a485-fa95d65a6d25
Route
ORAL
Published
Effective Date 2023-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Acesulfame Potassium Butylparaben Anhydrous Citric Acid Glycerin High Fructose Corn Syrup Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sorbitol Solution Magnesium Aluminum Silicate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-06
Description

(in each 5 mL) Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

(in each 5 mL) Acetaminophen 160 mg

Uses
  • reduces fever
  • minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
Section 42229-5

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

American Health Packaging

Columbus, OH 43217

T0966C050423

R04/23

Section 50565-1

Keep out of reach of children.

Section 50567-7

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

Section 50568-5

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

Section 50569-3

Ask a doctor before use if your child has liver disease.

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 throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • 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 (lb)

Age (yr)

Dose (mL)

or as directed by a doctor

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 unit dose cup)

36-47

4-5 years

7.5 mL (1.5 unit dose cups)

48-59

6-8 years

10 mL (2 unit dose cups)

60-71

9-10 years

12.5 mL (2.5 unit dose cups)

72-95

11 years

15 mL (3 unit dose cups)
Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Active Ingredient

(in each 5 mL)

Acetaminophen 160 mg

Other Information
  • each 5 mL contains: sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)

    grape flavored suspension supplied in the following oral dosage form:

    5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-762-17

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 children even if you do not notice any sign or symptoms.

Inactive Ingredients:

acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

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.

Principal Display Panel – Cup – 160 Mg/5 Ml

NDC 60687- 762-40

CHILDREN’S

ACETAMINOPHEN

ORAL SUSPENSION

Pain Reliever-Fever Reducer

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Delivers 5 mL

SHAKE WELL BEFORE USING

See package Drug Facts inert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0966C50423

Principal Display Panel – Tray – 160 Mg/5 Ml

Case NDC 60687-762-17/Cup NDC 60687-762-40

Children’s Acetaminophen

Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T0966C050423            R04/23

Structured Label Content

Uses
  • reduces fever
  • minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
Section 42229-5 (42229-5)

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

American Health Packaging

Columbus, OH 43217

T0966C050423

R04/23

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease.

Purpose

Pain reliever/fever reducer

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 throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • 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 (lb)

Age (yr)

Dose (mL)

or as directed by a doctor

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 unit dose cup)

36-47

4-5 years

7.5 mL (1.5 unit dose cups)

48-59

6-8 years

10 mL (2 unit dose cups)

60-71

9-10 years

12.5 mL (2.5 unit dose cups)

72-95

11 years

15 mL (3 unit dose cups)
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Active Ingredient (Active ingredient)

(in each 5 mL)

Acetaminophen 160 mg

Other Information (Other information)
  • each 5 mL contains: sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)

    grape flavored suspension supplied in the following oral dosage form:

    5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-762-17

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 children even if you do not notice any sign or symptoms.

Inactive Ingredients:

acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions Or Comments? (Questions or Comments?)

Call 1-800-845-8210.

Stop Use and Ask A Doctor If: (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.

Principal Display Panel – Cup – 160 Mg/5 Ml (Principal Display Panel – Cup – 160 mg/5 mL)

NDC 60687- 762-40

CHILDREN’S

ACETAMINOPHEN

ORAL SUSPENSION

Pain Reliever-Fever Reducer

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Delivers 5 mL

SHAKE WELL BEFORE USING

See package Drug Facts inert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0966C50423

Principal Display Panel – Tray – 160 Mg/5 Ml (Principal Display Panel – Tray – 160 mg/5 mL)

Case NDC 60687-762-17/Cup NDC 60687-762-40

Children’s Acetaminophen

Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T0966C050423            R04/23

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:56.770486 · Updated: 2026-03-14T23:04:17.676959