OTC Medication Information: CVS Effervescent Pain Relief PM

CVS EFFERVESCENT PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet
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.

Drug Facts

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

Warnings

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

Ask a doctor before use if you have

liver disease
a breathing problem such as emphysema, or chronic bronchitis
trouble urinating due to enlarged prostate gland
glaucoma

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 or operate machinery

Stop use and ask a doctor if

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

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

Adults and children 12 years and over

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

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

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.

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

CVS Effervescent Pain Relief PM
(click image for full-size original)
CVS EFFERVESCENT PAIN RELIEF PM
acetaminophen and diphenhydramine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-577
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
POLYETHYLENE GLYCOLS
POLYSORBATE 80
POTASSIUM BICARBONATE
POVIDONES
DIMETHICONE
SODIUM BENZOATE
SODIUM BICARBONATE
SUCRALOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 15mm
Flavor BERRY Imprint Code RP177
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-577-16 16 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 02/02/2015
Labeler — CVS Pharmacy (062312574)

Revised: 02/2015 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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