FDA Label for Acetaminophen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH GELTAB)
- 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?
- PRINCIPAL DISPLAY PANEL - 650 MG GELTAB BOTTLE LABEL
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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 Geltab)
Acetaminophen USP, 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. Sever liver damage may occur if you take
• more than 6 geltabs in 24 hours, which is the maximum daily amount• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening
• skin reddening• blisters• rashif 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.• 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• the tablet got stuck in your throat
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 geltabs every 8 hours. Swallow only one geltab at a time.• take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).• swallow whole - do not crush, chew, split or dissolve• do not take more than 6 geltabs 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 high humidity.• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients
Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide
Questions?
Call 1-800-406-7984
Principal Display Panel - 650 Mg Geltab Bottle Label
Well at
Walgreens
Arthritis
Pain Reliever
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever / Fever Reducer
• For the temporary relief of minor arthritis pain
• Easy-open bottle • Last up to 8 hours
80 GELTABS*
(*Gelatin-Coated Tablets)
Compare to Tylenol® 8HR Arthritis Pain active ingredient‡‡
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
NDC 0363-0340-08
* Please review the disclaimer below.