COUNTERACT PM- acetaminophen and diphenhydramine tablet

CounterAct by

Drug Labeling and Warnings

CounterAct by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc., Advance Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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 are allergic to acetaminophen or any of the ingredients in this product

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, which is the maimum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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 searious underlying medical illness.
• new symptoms occur
• redness or swelling is present
• pain gets worse of lasts more than 10 days
• fever gets worse or lasts more than 3 days

These could be signs of a serious condition

WARNINGS

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Keep out of reach of children

Purpose

Pain reliever

Nighttime sleep-aid

Directions

do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: do not use.

Other Information

• store at controlled room temperature 15-30 oC (59-86 oF)
• see end flap for expiration date and lot number

Questions or comments?

If you have any questions or comments, or to report an adverse even, please contact 1-800-282-3000.

Inactive ingredients

calcium carbonate, corn starch, citric acid, croscarmellose sodium, hypromellose, lactose, magnesium silicate,

magnesium stearate, maltodextrin, microcrystalline cellulose, medium-chain triglyceride, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium carbonate, sodium starch glycolate, stearic acid.

Do not take this product unless directed by a doctor if you have

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

Uses

temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUNTERACT  PM
acetaminophen and diphenhydramine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-304
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PYRROLIDONE (UNII: KKL5D39EOL)
SODIUM CARBONATE (UNII: 45P3261C7T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (no color added)	Score	no score
Shape	CAPSULE (Caplet)	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-304-01	1 in 1 BOX	05/02/2016
1	NDC: 54473-304-50	50 in 1 BOTTLE; 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	05/02/2016

Labeler - Melaleuca, Inc. (139760102)

Registrant - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical		078301063	manufacture(54473-304)