Indications and uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Headache Relief PM
- Manufacturer
- Valu Merchandisers Company | LNK International, Inc.
- Effective date
- 2024-07-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:58:05
Label at a glance#
ProductHeadache Relief PM
Active ingredientACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE
Label structure9 sections
Dosage and administration
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
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.bestchoicebrand.com
www.bestchoicebrand.com
www.bestchoicebrand.comLabel contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Pain reliever
Nighttime sleep-aid
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
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:
- hives
- facial swelling
- shock
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- 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 of acetaminophen in 24 hours
- 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
Do not use
- 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 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
Ask a doctor before use if
- 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
Ask a doctor or pharmacist before use if you are taking
- a prescription drug for:
- diabetes
- gout
- arthritis
- 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
When using this product
- avoid alcoholic beverages
- drowsiness may occur
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- 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
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- redness or swelling is present
- new symptoms occur
- 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.
If pregnant or breast-feeding,
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.
Keep out of reach of children.
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.
Directions
- 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
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, 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
Questions or comments?
1-800-426-9391
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® PM HEADACHE†
Best
Choice®
Headache Relief PM
ACETAMINOPHEN
Aspirin (NSAID)
Diphenhydramine citrate
Pain Reliever/Nighttime Sleep Aid
Caffeine Free
Actual Size
50 Caplets
Non-Habit Forming
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.
50844 REV0418A67415
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106
Best Choice®
100% Guaranteed
www.bestchoicebrand.com
Products#
Every source-derived product name is available through these pages.
- Headache Relief PM
- Acetaminophen, Aspirin, Diphenhydramine citrate
- ACETAMINOPHEN
- ASPIRIN
- DIPHENHYDRAMINE CITRATE
- DIPHENHYDRAMINE
- STARCH, CORN
- CROSPOVIDONE, UNSPECIFIED
- FD&C BLUE NO. 1 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- MALTODEXTRIN
- MEDIUM-CHAIN TRIGLYCERIDES
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POVIDONE, UNSPECIFIED
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- SODIUM SULFATE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- FERRIC OXIDE YELLOW
- ZINC STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63941-674 | 63941-674-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5568459e-f5f0-467f-b264-efb241db084a | 2547f2ca-ea36-4ded-8a51-fb83b293d336 | 2024-07-26 | Warnings | 5568459e-f5f0-467f-b264-efb241db084a 2547f2ca-ea36-4ded-8a51-fb83b293d336 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.