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Assured Headache PM (Aspirin Free)

Medically reviewed by Drugs.com. Last updated on Dec 26, 2019.

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: Spirit Pharmaceutical LLC
NDC Code: 68210-0020

Assured™ Headache PM (Aspirin Free)

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine citrate 38 mgNighttime 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 2 caplets in 24 hours, which is the maximum daily amount
  • 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 or general allergic reaction occurs, stop use and seek medical help right away.

Do not use
  • if you are allergic to acetaminophen
  • 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

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
  • any new symptoms occur
  • sleeplessness lasts 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
  • painful area is red or swollen
  • fever gets worse or lasts more than 3 days

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. 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
  • do not use in children under 12 years of age
  • adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor

Other information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using. Keep this box for important information.

Inactive ingredients

colloidal silicon dioxide, FD&C Blue # 1, FD&C blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide

Questions or comments?

1-888-333-9792

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton

ASSURED

COMPARE TO ACTIVE INGREDIENTS OF
EXCEDRIN ® PM*

ASPIRIN FREE

Headache PM

  • Acetaminophen 500 mg

    Pain Reliever

  • Diphenhydramine Citrate 38 mg

    Nighttime Sleep-Aid

Actual Size
NON HABIT FORMING

20 caplets

ASSURED HEADACHE PM (ASPIRIN FREE) 
acetaminophen and diphenhydramine citrate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0020
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE K30 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize18mm
FlavorImprint CodeS26
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0020-31 BOTTLE in 1 CARTON
120 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/12/2016
Labeler - Spirit Pharmaceutical LLC (179621011)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceutical Ltd915664486manufacture(68210-0020)

 
Spirit Pharmaceutical LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.