Assured Headache PM (Aspirin Free)

Generic name: Acetaminophen and Diphenhydramine Citrate

Spirit Pharmaceutical LLC

Dosage Form

N/A

Manufacturer

Spirit Pharmaceutical LLC

Active ingredients

ACETAMINOPHEN500 mg
DIPHENHYDRAMINE CITRATE38 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

68210-4135-2

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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

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Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.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

Do not use if…Keep out of reach of children.

Ask a doctor before use 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 fe…

Ask a doctor or pharmacist before use if…taking the blood thinning drug warfarin taking sedatives or tranquilizers

Stop use and talk to a doctor if…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 p…

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

Package labelHeadache PM Acetaminophen 500 mg - Pain Reliever Diphenhydramine Citrate 38 mg - Nighttime Sleep-aid Aspirin Free Non habit forming 20 Caplets