Acetaminophen Oral Suspension Grape

Acetaminophen Oral Suspension Grape
SPL v1
SPL
SPL Set ID 38070d15-2678-4e59-e063-6294a90ab690
Route
ORAL
Published
Effective Date 2024-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Fd&c Blue No. 1 Glycerin Microcrystalline Cellulose Carboxymethylcellulose Sodium Potassium Sorbate Water Sorbitol Sucralose Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-20
Description

Active ingredient (in each 5mL)                                             Purpose Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

Medication Information

Description

Active ingredient (in each 5mL)                                             Purpose Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

Uses

temporarily: reduces fever

relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
Section 51945-4

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more then 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, persist or 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 anyof the inactive ingredients in this product.
Directions
  • This product does not contain directions or complete warnings

for adult use

  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL=milliliter
  • find the 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 (tsp or mL)

under 24

under 2

ask a doctor

24 to 35

2 to 3

1 tsp or 5 mL

36 to 47

4 to 5

1 1/2 tsp or 7.5 mL

48 to 59

6 to 8

2 tsp or 10 mL

60 to 71

9 to 10

2 1/2 tsp or 12.5 mL

72 to 95

11

3 tsp or 15 mL

*or as directed by a doctor

  • Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Active Ingredient

Active ingredient(in each 5mL)                                             Purpose

Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

Other Information
  • Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.
Overdose Warning:

In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients

Anhydrous Citric Acid, D&C Red #33, FD&C Blue #1, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.

Questions Or Comments?

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC.

Leland, NC-28451

Stop Use and Ask A Doctor If
  • pain gets worse or lasts for more then 5 days
  • fever gets worse or last for more then 3 days
  • new symptoms occur redness or swelling is present. These could be signs of a serious condition. 

Keep Out of Reach of Children

Ask A Doctor Or Pharmacist Before Use If the Child Has

liver disease.

Ask  Doctor Or Pharmacist Before Use If Your Child Is 

taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning)

Structured Label Content

Uses

temporarily: reduces fever

relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
Section 51945-4 (51945-4)

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more then 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, persist or 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 anyof the inactive ingredients in this product.
Directions
  • This product does not contain directions or complete warnings

for adult use

  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL=milliliter
  • find the 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 (tsp or mL)

under 24

under 2

ask a doctor

24 to 35

2 to 3

1 tsp or 5 mL

36 to 47

4 to 5

1 1/2 tsp or 7.5 mL

48 to 59

6 to 8

2 tsp or 10 mL

60 to 71

9 to 10

2 1/2 tsp or 12.5 mL

72 to 95

11

3 tsp or 15 mL

*or as directed by a doctor

  • Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Active Ingredient

Active ingredient(in each 5mL)                                             Purpose

Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

Other Information
  • Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.
Overdose Warning: (Overdose warning:)

In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients

Anhydrous Citric Acid, D&C Red #33, FD&C Blue #1, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC.

Leland, NC-28451

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts for more then 5 days
  • fever gets worse or last for more then 3 days
  • new symptoms occur redness or swelling is present. These could be signs of a serious condition. 

Keep Out of Reach of Children (Keep out of Reach of children)

Ask A Doctor Or Pharmacist Before Use If the Child Has (Ask a doctor or pharmacist before use if the child has)

liver disease.

Ask  Doctor Or Pharmacist Before Use If Your Child Is  (Ask  doctor or pharmacist before use if your child is )

taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.842888 · Updated: 2026-03-14T23:09:05.302478