CVS EFFERVESCENT PAIN RELIEF PM- acetaminophen and diphenhydramine tablet

CVS by

Drug Labeling and Warnings

CVS by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
POVIDONES (UNII: FZ989GH94E)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	15mm
Flavor	BERRY	Imprint Code	RP177
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-577-16	16 in 1 CARTON; Type 0: Not a Combination Product

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)