FDA Label for Cvs Effervescent Pain Relief Pm
View Indications, Usage & Precautions
Cvs Effervescent Pain Relief Pm Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.
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Drug Facts
Distributed By: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket RI 02895
CVS.com
1-800-SHOP CVS
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.
Tamper Evident: Do not use if individual pouch is torn or open. This is not a child resistant package. Keep out of reach of children.
Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Diphenhydramine 25 mg
Purpose
Pain Reliever/fever reducer
Nighttime sleep-aid
Uses
temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness
Liver Warning
This product contains acetaminophen. Severe liver damage can 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.• with any other product containing diphenhydramine, even one used on skin• in children under 12 years of age• if you ever had an allergic reaction to this product or any of its ingredients• liver disease• a breathing problem such as emphysema, or chronic bronchitis• trouble urinating due to enlarged prostate gland• glaucoma
Ask a doctor before use if you have
Ask A Doctor Or Pharmacist Before Use If You Are
• taking the blood thinning drug warfarin• taking sedatives or tranquilizers• drowsiness will occur• avoid alcoholic beverages• do not drive or operate machinery• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.• 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• new symptoms occur
When Using this product
Stop use and ask a doctor if
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 at 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)• dissolve tablets fully in 8 oz of water at room temperature• do not chew or swallow tablet• take 2 tablets fully dissolved in 8 oz of water at room temperature at bedtime• do not take more than 2 tablets in 24 hours
Adults and children 12 years and over | |
children under 12 years | do not use |
Other Information
• each tablet contains: potassium 156 mg; sodium 165 mg• store between 20-25°C (68-77°F). Avoid excessive heat.• do not use if individual pouch is torn or open
Inactive Ingredients
anhydrous citric acid, FD&C red 40, flavor, polyethylene glycol, polysorbate, potassium bicarbonate, povidone, simethicone, sodium benzoate, sodium bicarbonate, sucralose
Questions Or Comments
1-866-467-2748
Principal Display Panel
Effervescent Pain Relief PM
Extra Strength
Acetaminophen 500mg, Diphenhydramine HCl 25mg
Compare to the active ingredient in Extra Strength Tylenol® PM**
Non-habit forming pain reliever/sleep aid
Aspirin & Ibuprofen free
For a restful night's sleep
No need to chew or swallow tablet
Berry flavor
16 Effervescent Tablets
* Please review the disclaimer below.