Topcare Headache PM Formula
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Topco Associates LLC
NDC Code: 36800-355
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.
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
(equiv. to Diphenhydramine citrate 38 mg)
Pain reliever
Nighttime sleep-aid
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- 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
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other product containing diphenhydramine, even one used on skin
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- in children under 12 years of age
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- if you have ever had an allergic reaction to this product or any of its ingredients
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- liver disease
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- glaucoma
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
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- drowsiness may occur
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
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- pain gets worse or lasts for more than 10 days
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- fever gets worse or lasts for more than 3 days
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- redness or swelling is present
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- new symptoms occur
These could be signs of a serious condition.
ask a health professional before use.
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.
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- do not use more than directed (see Liver warning)
adults and children 12 years of age and over:
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- take 2 tablets at bedtime, if needed, or as directed by a doctor
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- do not take more than 2 tablets of this product in 24 hours
children under 12 years of age:
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- do not use
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- store at 20-25°C (68-77°F)
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
1-888-423-0139
NON-HABIT FORMING
Headache PM Formula
ACETAMINOPHEN
DIPHENHYDRAMINE HCl
Aspirin Free - Pain Reliever / Nighttime Sleep Aid
actual size
COMPARE TO EXCEDRIN® PM active ingredients
| TOPCARE HEADACHE PM FORMULA
acetaminophen, diphenhydramine hcl tablet, film coated |
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| Labeler - Topco Associates LLC (006935977) |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
