Headache Relief PM by Valu Merchandisers Company
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: Valu Merchandisers Company
NDC Code: 63941-674
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 250 mg
Aspirin 250 mg (NSAID*)
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
- facial swelling
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
- have had stomach ulcers or bleeding problems
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen or others]
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
- in children under 12 years of age
- with any other drug containing acetaminophen (prescription or non prescription). 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
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have glaucoma
- you have asthma
- you have difficulty in urination due to enlargement of the prostate gland
- you are taking a diuretic
- you have a breathing problem such as emphysema or chronic bronchitis
- you have liver disease
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- a prescription drug for:
- any other drug, or are under a doctor's care for any serious condition
- sedatives or tranquilizers
- any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
- drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts for more than 10 days
- painful area is red or swollen
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
These could be signs of a serious condition.
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
- adults and children 12 years and over: take 2 caplets at bedtime, with a full glass of water
- do not take more than 2 caplets in 24 hours, unless directed by a doctor
- children under 12 years: do not use
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate
COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® PM HEADACHE†
Headache Relief PM
Pain Reliever / Nighttime Sleep Aid
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Novartis AG, owner of the registered trademark Excedrin® PM Headache.
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106
|HEADACHE RELIEF PM
acetaminophen, aspirin, diphenhydramine citrate tablet, film coated
|Labeler - Valu Merchandisers Company (868703513)|
|LNK International, Inc.||038154464||PACK(63941-674)|
|LNK International, Inc.||832867894||MANUFACTURE(63941-674)|
|LNK International, Inc.||967626305||PACK(63941-674)|
|LNK International, Inc.||868734088||PACK(63941-674)|
Medically reviewed on Nov 17, 2018