FDA Label for Acetaminophen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (PER 5 ML = 1 TEASPOONFUL)
- PURPOSE
- USES:
- WARNINGS:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- PRINCIPAL DISPLAY PANEL
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Safecor Health, Llc. 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.
Active Ingredient (Per 5 Ml = 1 Teaspoonful)
Acetaminophen 160 mg
Purpose
Pain Reliever / Fever Reducer
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:
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:
- more than 5 doses is taken 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
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
a liver disease.
Ask A Doctor Before Use If You Are
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
Directions:
- Do not take more than directed
- Find dose in chart below
- If possible, use weight to dose, otherwise use age
- Dosage may be repeated 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 mL (tsp) | Consult Physician | 5 mL (1 tsp ) | 7.5 mL (1 1/2 tsp) | 10 mL (2 tsp) | 12.5 mL (2 1/2 tsp) | 15 mL (3 tsp) | 20 mL (4 tsp) |
Other Information:
- Store at room temperature 15°C- 30°C (59°F-86°F)
- Protect from freezing
- Protect from light
- Aspirin Free
- Alcohol Free
- TAMPER-EVIDENT: Do not use if foil seal over syringe blister is torn, broken, or missing or if endcap is broken, missing, or separated from syringe.
- For more info call 1-800-447-1006
Inactive Ingredients:
Artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Principal Display Panel
SAFECOR HEALTH
NDC 48433-401-05
Acetominophen Oral Liquid
160 mg / 5 mL
(Delivers 5 mL)
* Please review the disclaimer below.