FDA Label for Children Acetaminophen Oral Solution
View Indications, Usage & Precautions
Children Acetaminophen Oral Solution Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (per 5 mL teaspoonful)
Acetaminophen 160 mg
Otc - Purpose
Purpose
Pain Reliever/Fever Reducer
Indications & Usage
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product
- skin reddening
- blisters
- rash
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor before use if you have liver disease.
Ask a doctor before use if you are taking the blood thinning drug warfarin.
When using this product: Do not exceed recommended dose.
Stop use and ask a doctor if
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
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.
Dosage & 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 | over 95 |
| Age (years) | under 2 | 2 to 3 | 4 to 5 | 6 to 8 | 9 to 10 | 11 | 12 to adult |
| 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) | 4 tsp (20 mL) |
Inactive Ingredient
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
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