LEADER HEADACHE PM FORMULA- acetaminophen, diphenhydramine hcl tablet, film coated

leader headache pm formula by

Drug Labeling and Warnings

leader headache pm formula by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

(equiv. to Diphenhydramine citrate 38 mg)

Purposes

Pain reliever

Nighttime sleep-aid

Uses

• for the 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.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

• avoid alcoholic drinks
• drowsiness may occur
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• 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 (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 use more than directed (see overdose warning)
• adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor
• do not take more than 2 tablets of this product in 24 hours
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

PRINCIPAL DISPLAY PANEL

DRUG: leader headache pm formula

GENERIC: Acetaminophen, Diphenhydramine HCl

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0824-0

COLOR: blue

SHAPE: ROUND

SCORE: No score

SIZE: 11 mm

IMPRINT: L355;PM

PACKAGING: 50 in 1 BOTTLE

ACTIVE INGREDIENT(S):

• ACETAMINOPHEN 500mg in 1
• DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

• CARNAUBA WAX
• POLYSORBATE 80
• POLYETHYLENE GLYCOLS
• POVIDONE
• STEARIC ACID
• CELLULOSE, MICROCRYSTALLINE
• CROSPOVIDONE
• HYPROMELLOSES
• MAGNESIUM STEARATE
• TITANIUM DIOXIDE

INGREDIENTS AND APPEARANCE

LEADER HEADACHE PM FORMULA 
acetaminophen, diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0824(NDC: 37205-677)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND (shallow convex)	Size	11mm
Flavor		Imprint Code	L355;PM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0824-0	50 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/15/2018

Labeler - REMEDYREPACK INC. (829572556)