40507559-aee4-a603-e063-6394a90afc4f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Dosage and Administration
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- Follow the instruction given on this carton for your easy use.
|
Age (Years) |
Dose (mL)* |
|
Under 2 Years |
Ask a doctor |
|
2 to under 6 |
1 Sachet (5 mL) |
|
6 to 11 years |
2 Sachets (10 mL) |
*dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor.
mL = milliliter
Description
Acetaminophen 160 mg
Uses
- Temporarily reduces fever
- Temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Section 34088-5
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Section 43683-2
Change in Direction
Section 44425-7
Other information
- store between 20-25°C (68-77°F)
- do not use if carton or sachet is torn, broken or punctured.
Section 50565-1
Keep out of reach of children.
Section 50566-9
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 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
Section 50570-1
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
Section 51727-6
Inactive Ingredient
anhydrous citric acid, FD&C Red No. 40, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
Section 51945-4
Section 53413-1
Question or Comments?
call 1-516-675-8915
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.
Active Ingredient (in Each 5 Ml)
Acetaminophen 160 mg
Structured Label Content
Uses
- Temporarily reduces fever
- Temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Dosage and Administration (34068-7)
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- Follow the instruction given on this carton for your easy use.
|
Age (Years) |
Dose (mL)* |
|
Under 2 Years |
Ask a doctor |
|
2 to under 6 |
1 Sachet (5 mL) |
|
6 to 11 years |
2 Sachets (10 mL) |
*dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor.
mL = milliliter
Section 34088-5 (34088-5)
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Section 43683-2 (43683-2)
Change in Direction
Section 44425-7 (44425-7)
Other information
- store between 20-25°C (68-77°F)
- do not use if carton or sachet is torn, broken or punctured.
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
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 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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive Ingredient
anhydrous citric acid, FD&C Red No. 40, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Question or Comments?
call 1-516-675-8915
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.
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))
Acetaminophen 160 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:37.622748 · Updated: 2026-03-14T23:12:56.390264