FDA.reportPublic FDA data

Assured Headache PM (Aspirin Free)

Manufacturer
Spirit Pharmaceutical LLC
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:50:13

Label at a glance#

ProductAssured Headache PM (Aspirin Free)
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE CITRATE
Label structure9 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, if needed, or as directed by a doctor

Storage and handling

store at controlled room temperature 20°-25°C (68°-77°F) 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)Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine citrate 38 mgNighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to acetaminophen
  • 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic drinks
  • drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • any new symptoms occur
  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • painful area is red or swollen
  • fever gets worse or lasts more than 3 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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, if needed, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using. Keep this box for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C Blue # 1, FD&C blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Headache PM
Acetaminophen 500 mg - Pain Reliever
Diphenhydramine Citrate 38 mg - Nighttime Sleep-aid

Aspirin Free

Non habit forming


20 Caplets

LabelLabel

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099872acetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN6
1099872acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral TabletSCD6
1099872APAP 500 MG / Diphenhydramine Citrate 38 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4135-2Assured Headache PM (Aspirin Free)1 in 1 CARTONTABLET, COATED16
68210-4135-2Assured Headache PM (Aspirin Free)20 in 1 BOTTLETABLET, COATED206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4135ASSURED HEADACHE PM (ASPIRIN FREE) (ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [SPIRIT PHARMACEUTICAL LLC]6Legacy NDC, 2 package rows20250101_d9d22e45-1a13-4b45-910d-1183a8e6ed7d.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-413568210-4135-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE CITRATE4OD433S209ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

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
2a806f57-022b-a1fc-e063-6394a90a1ffad9d22e45-1a13-4b45-910d-1183a8e6ed7d2024-12-30WarningsExact identifier
spl id: 2a806f57-022b-a1fc-e063-6394a90a1ffa
spl set id: d9d22e45-1a13-4b45-910d-1183a8e6ed7d

Reported adverse events (FAERS/openFDA)#

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