FDA Label for Pain Relief Extra Strength
View Indications, Usage & Precautions
Pain Relief Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan), Ltd.. 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.
Other
Drug Facts
Active Ingredient (In Each Capsule)
Acetaminophen 500 mg
Purpose
Pain reliever/ fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 softgels (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 have ever had an allergic reaction to this product or any of its ingredients
Stop Use And Ask A Doctor If
- 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
These could be signs of a serious condition.
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 for children even if you do not notice any signs or symptoms.
Directions
- Do not take more than directed (see Overdose warning)
- take 2 softgels every 4 to 6 hours while symptoms last
- do not take more than 6 softgels in 24 hours unless directed by a doctor
- do not take more than 10 days unless diredted by doctor
Adults and children 12 years of age and over | |
Children 12 years of age | ask a doctor |
Other Information
- store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China
Principal Display Panel - Shipping Label
ACETAMINOPHEN CAPSULES, 500 mg
Quantity : 3000 Capsules
NDC. No : 53345-019-01
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.