FDA Label for Sunmark Arthritis Pain Reliever
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST 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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sunmark Arthritis Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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 (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
Warnings
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• 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.• if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If You Have
liver disease
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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• 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 at 20-25°C (68-77°F). Avoid excessive heat 40°C (104°F).
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions Or Comments?
1-800-719-9260
Principal Display Panel
COMPARE TO TYLENOL® 8HR ARTHRITIS PAIN ACTIVE INGREDIENT
See New Warning
arthritis pain reliever
Acetaminophen
Extended-Release Tablets, 650 mg
Pain reliever/Fever reducer
For the Temporary Relief of Minor Arthritis Pain
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
100 CAPLETS* - 650 mg EACH
GLUTEN FREE
*Capsule-Shaped Tablets
* Please review the disclaimer below.