HEADACHE RELIEF PM

Manufacturer
Walgreens | Spirit Pharmaceuticals LLC | MOLECULES DRUGS & RESEARCH LABORATORY PVT. LTD.
Effective date
2017-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:24

Label at a glance#

ProductHEADACHE RELIEF PM
Active ingredientACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE
Label structure10 sections

Indications and uses

For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

do not use more than directed do not use in children under 12 years of age adults and children 12 years of age 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

Storage and handling

store at 20°-25°C (68°-77°F). close cap tightly after use. read all product information before using. Keep this box for important information.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purposes
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID) * Pain reliever
Diphenhydramine citrate 38mgNighttime sleep-aid

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • 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

OTC - ASK DOCTOR SECTION

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have glaucoma
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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
  • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
  • sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask doctor if

OTC - STOP USE SECTION

  • 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
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • pain gets worse or last for more than 10 days
  • painful area is red or swollen
  • ringing in the ears or a loss of hearing occurs
  • any new symptoms occur

These could be signs of a serious condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

DOSAGE & ADMINISTRATION SECTION

do not use more than directed

  • do not use in children under 12 years of age
  • adults and children 12 years of age 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

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F).
  • close cap tightly after use.
  • read all product information before using. Keep this box for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoic acid , calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, iron oxide yellow, maltodextrin, magnesium stearate, microcrystalline cellulose Type 101, microcrystalline cellulose Type 112, medium chain triglycerides, Opadry Blue, pregelatinized corn starch, polysorbate 80, povidone K30, stearic acid, talc, zinc stearate

Questions or comments

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Well at
Walgreens

NDC 0363-9894-12

WALGREENS PHARMACIST RECOMMENDED ‡

Headache
Relief PM

Acetaminophen / Pain Reliever
Aspirin (NSAID) / Pain Reliever
Diphenhydramine Citrate / Nighttime Sleep Aid

  • Caffeine free
  • Non-habit forming

NIGHTTIME

100 CAPLETS

Compare to Excedrin ® PM Headache Triple
Action Formula Caplets active ingredients ‡‡

image description
image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN2
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral TabletSCD2
1593110APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9894-122020-01-31C16284748780-19d75b9cf-eb3a-f424-e053-dadaa90a57ceHEADACHE RELIEF PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9894-12HEADACHE RELIEF PM100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
0363-9894-12HEADACHE RELIEF PM1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9894HEADACHE RELIEF PM (ACETAMINOPHEN, ASPIRIN, AND DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [WALGREENS]2Legacy NDC, 2 package rows20171213_7af271d5-94e9-4a08-a9f2-270854089de7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9894-12EA - Each0363-98944aa32a97-7433-4f7b-b5a3-cea6c8e6df7212022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-98940363-9894-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
603d483b-3319-434a-e053-2a91aa0a53697af271d5-94e9-4a08-a9f2-270854089de72017-12-13WarningsExact identifier
spl id: 603d483b-3319-434a-e053-2a91aa0a5369
spl set id: 7af271d5-94e9-4a08-a9f2-270854089de7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.