Children's Acetaminophen Oral Suspension
38b839b6-de7d-4f33-a19a-efc92cdad92c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 160 mg.........................................Pain reliever/fever reducer
Medication Information
Description
Acetaminophen 160 mg.........................................Pain reliever/fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pain due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Section 42229-5
R08/22
Distributed by:
M AJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Warnings
Liver warning: This product contains 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 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 (lb) | Age (yr) | Dose (mL) * |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
* or as directed by a doctor
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 has liver disease.
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
When using this product, do not exceed the 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.
Other Information
- each 5 mL contains: sodium 2 mg
- Store at 20° to 25°C (68° to 77°F)
- a red, strawberry flavored suspension supplied in the following oral dosage form:
NDC 0904-7278-41: 5 mL unit dose cup, in a tray of ten cups
Inactive Ingredients:
acesulfame K, butylparaben, citric acid, FD&C Red No. 40, 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.
Keep Out of the 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 children even if you do not notice any sign or symptoms
Principal Display Panel 5 Ml Unit Dose Cup
MAJOR®
0904-7278-41
Children's Acetaminophen Oral Suspension
160 mg per 5 mL
Pain Reliever • Fever Reducer
Ibuprofen Free/ Alcohol Free / Aspirin Free
SHAKE WELL
Delivers 5 mL • See insert
For Institutional Use Only
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
F1781C050822
Active Ingredient
Acetaminophen 160 mg.........................................Pain reliever/fever reducer
Structured Label Content
Uses
temporarily:
- reduces fever
- relieves minor aches and pain due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Section 42229-5 (42229-5)
R08/22
Distributed by:
M AJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Warnings
Liver warning: This product contains 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 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 (lb) | Age (yr) | Dose (mL) * |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
* or as directed by a doctor
Do Not Use (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 has liver disease.
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
When using this product, do not exceed the 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.
Other Information (Other information)
- each 5 mL contains: sodium 2 mg
- Store at 20° to 25°C (68° to 77°F)
- a red, strawberry flavored suspension supplied in the following oral dosage form:
NDC 0904-7278-41: 5 mL unit dose cup, in a tray of ten cups
Inactive Ingredients: (Inactive ingredients:)
acesulfame K, butylparaben, citric acid, FD&C Red No. 40, 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.
Keep Out of the Reach of Children. (Keep out of the 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 children even if you do not notice any sign or symptoms
Principal Display Panel 5 Ml Unit Dose Cup (PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup)
MAJOR®
0904-7278-41
Children's Acetaminophen Oral Suspension
160 mg per 5 mL
Pain Reliever • Fever Reducer
Ibuprofen Free/ Alcohol Free / Aspirin Free
SHAKE WELL
Delivers 5 mL • See insert
For Institutional Use Only
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
F1781C050822
Active Ingredient (Active ingredient )
Acetaminophen 160 mg.........................................Pain reliever/fever reducer
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Source: dailymed · Ingested: 2026-02-15T12:05:25.005825 · Updated: 2026-03-14T23:07:10.032470