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

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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Cardinal Health Headache PM Formula Drug Facts

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

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

Remedy_Label

LEADER HEADACHE PM FORMULA 
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0824(NDC:37205-677)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeROUND (shallow convex) Size11mm
FlavorImprint Code L355;PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0824-050 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201805/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/15/201805/06/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2020
 
REMEDYREPACK INC.