Reese Headache Powders

Manufacturer
Reese Pharmaceutical Co | Pharbest
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:35

Label at a glance#

ProductReese Headache Powders
Active ingredientCAFFEINE, ASPIRIN
Label structure12 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache toothache menstrual cramps muscular aches minor arthritis pain colds temporarily reduces fever

Dosage and administration

adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid. do not take more than 4 powders in 24 hours unless directed by a doctor. children under 12 years of age: ask a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each powder)

Aspirin (NSAID*) 845 mg

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each powder)

Caffeine 65 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • menstrual cramps
    • muscular aches
    • minor arthritis pain
    • colds
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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)

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 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup ocoffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this productbecause too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for diabetes, gout, or arthritis

When using this product

OTC - WHEN USING SECTION

limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a 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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.
  • do not take more than 4 powders in 24 hours unless directed by a doctor.
  • children under 12 years of age: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • each powder contains: potassium 55 mg
  • store below 25ºC (77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

docusate sodium, fumaric acid, lactose monohydrate, potassium chloride

Questions or comments?

OTC - QUESTIONS SECTION

Reese Pharmaceutical 1-800-321-7178

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Headache Powders

Display Panel Headache PowdersDisplay Panel Headache Powders

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
994435aspirin 845 MG / caffeine 65 MG Oral PowderPSN4
994435aspirin 845 MG / caffeine 65 MG Oral PowderSCD4
994435ASA 845 MG / Caffeine 65 MG Oral PowderSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-501REESE HEADACHE POWDERS (ASPIRIN AND CAFFEINE) POWDER [REESE PHARMACEUTICAL CO]4Current NDC, Legacy NDC20241220_386f7a6c-4bfc-4140-a67b-07f6b520d58f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10956-50110956-501-18, 10956-501-24, 10956-501-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
Reese Headache PowdersASPIRIN AND CAFFEINEReese Pharmaceutical Co386f7a6c-4bfc-4140-a67b-07f6b520d58f2024-12-18WarningsExact identifier
ndc (package): 10956-501-18
ndc (package): 10956-501-24
ndc (package): 10956-501-50
ndc (product): 10956-501
ndc11 (package): 10956050118
ndc11 (package): 10956050150
ndc11 (package): 10956050124
spl id: 59f6b9f3-3f6d-44c4-a7f3-29fe49cf97bc
spl set id: 386f7a6c-4bfc-4140-a67b-07f6b520d58f

Reported adverse events (FAERS/openFDA)#

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