FDA Label for Arthritis Pain
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Arthritis Pain Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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 Caplet)
Acetaminophen 650 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
- temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
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 this product
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist 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
- 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.
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.
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 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
- ask a doctor
adults | |
under 18 years of age |
Other Information
- store between 20-25°C (68-77°F)
- retain carton for complete product information and warnings
Inactive Ingredients
hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments?
1-844-705-4384
Principal Display Panel
DISCOUNT DRUG MART FOOD FAIR
NDC 53943-200-02
†Compare to the active ingredient in Tylenol® 8HR Arthritis Pain
8 Hour
Arthritis Pain
Acetaminophen Extended Release Tablets, 650mg
Pain Reliever/Fevere Reducer
For the temporary relief of minor arthritis pain
Actual Size
50 CAPLETS** - 650 MG EACH
**Capsule-Shaped Bi-Layer Tablets
* Please review the disclaimer below.