Assured Headache PM (Aspirin Free)
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: Spirit Pharmaceutical LLC
NDC code: 68210-0020
Medically reviewed by Drugs.com. Last updated on Dec 16, 2024.
Drug Facts
Active ingredients (in each caplet) | Purpose |
---|---|
Acetaminophen 500 mg | Pain reliever |
Diphenhydramine citrate 38 mg | Nighttime sleep-aid |
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
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
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.
- 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
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- avoid alcoholic drinks
- drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- 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.
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
- 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
- store at controlled room temperature 20°-25°C (68°-77°F)
- read all product information before using. Keep this box for important information.
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
1-888-333-9792
DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
ASSURED HEADACHE PM (ASPIRIN FREE)
acetaminophen and diphenhydramine citrate tablet, coated |
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Labeler - Spirit Pharmaceutical LLC (179621011) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Elysium Pharmaceutical Ltd | 915664486 | manufacture(68210-0020) |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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