FDA Label for Qaulity Choice Pain Relief Regular Strength
View Indications, Usage & Precautions
Qaulity Choice Pain Relief Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc. 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
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. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Sever liver damage may occur if you take
- more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyd ay while using this product
- skin reddening
- blisters
- rash
- If a skin reaction occurs, stop use and seek mdical help right away.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
Allergy alert: acetaminophen may cause sever skin reactions. Symptoms may include:
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 you are allergic to acetaminophen or any of the inactive ingredients in thris product.
Ask a doctor before use if you have liver disease
Ask a doctor before use if you are taking the blodd thinning drug warfarin.
When using this product: Do not exceed recomended dose.
Stop use and ask a doctor if:
These could be signs of a serious condition.
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 midcal help or contact a Poison Control Center right away at 1-800-222-1222. 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 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 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, porpylparaben, purified water, sodium citrate, sucralose.
Otc - Questions
Question or comments? 1-800-540-3765
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