ACETAMINOPHEN PM- acetaminophen, diphenhydramine hcl solution
CVS PHARMACY
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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CVS 44-058 Delisted
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Liver warning: This product contains acetaminophen. 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
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.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- liver disease
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Directions
-
do not take more than directed
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- adults and children 12 years and over: take 30 mL in the dosing cup provided at bedtime. Do not take more than 30 mL of this product in 24 hours.
- children under 12 years: do not use
Other information
-
each 30 mL dose cup contains: sodium 11 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium saccharin, sucralose
Principal display panel
CVS
Health™
Compare to the active ingredients
in Extra Strength Tylenol® PM*
Liquid
EXTRA STRENGTH
Acetaminophen PM
ACETAMINOPHEN, 1,000 mg
DIPHENHYDRAMINE HCl, 50 mg
Pain reliever/
Nighttime sleep aid
Alcohol free
8 FL OZ (237 mL)
Mixed Berry
F-058-19
REV0918A
*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Extra
Strength Tylenol® PM.
50844 REV0918A05819
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com®
1-800-SHOP CVS V-11112
CVS Health 44-058 REV0918A
| ACETAMINOPHEN PM
acetaminophen, diphenhydramine hcl solution |
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| Labeler - CVS PHARMACY (062312574) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | manufacture(69842-758) , pack(69842-758) | |