Headache Formula PM
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: SUPERVALU INC.
NDC Code: 41163-373
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 citrate 38 mg
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 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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
- 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 beverages
- be careful when driving a motor vehicle or operating machinery
- drowsiness may occur
- sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- painful area is red or swollen
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets at bedtime. Do not take more than 2 tablets of this product in 24 hours.
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide
compare to Excedrin® PM
headache formula PM
and diphenhydramine citrate
pain reliever / nighttime sleep-aid
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
Contact us at 1-877-932-7948, or
|HEADACHE FORMULA PM
acetaminophen and diphenhydramine citrate tablet, film coated
|Labeler - SUPERVALU INC. (006961411)|
|LNK International, Inc.||832867894||MANUFACTURE(41163-373)|
|LNK International, Inc.||038154464||PACK(41163-373)|
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.