Headache Formula PM by SUPERVALU INC. / LNK International, Inc. Equaline 44-373
Headache Formula PM by
Drug Labeling and Warnings
Headache Formula PM by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
HEADACHE FORMULA PM- acetaminophen and diphenhydramine citrate tablet, film coated
SUPERVALU INC.
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.
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Equaline 44-373
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
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
Do not use
- 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
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
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 beverages
- be careful when driving a motor vehicle or operating machinery
- drowsiness may occur
Stop use and ask a doctor if
- 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.
Keep out of reach of children.
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.
Directions
- 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
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
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
Principal Display Panel
equaline®
compare to Excedrin® PM
active ingredients*
NDC: 41163-373-12
headache formula PM
acetaminophen
and diphenhydramine citrate
aspirin free
pain reliever / nighttime sleep-aid
100 tablets
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.
50844 REV0712A37312
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
Contact us at 1-877-932-7948, or
www.supervalu-ourownbrands.com
Equaline 44-373
| HEADACHE FORMULA PM
acetaminophen and diphenhydramine citrate tablet, film coated |
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| Labeler - SUPERVALU INC. (006961411) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(41163-373) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(41163-373) | |