FDA Label for Assured Headache Pm (aspirin Free)

Other

Drug Facts

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

Otc - Purpose

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton - assured 01