Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets

Manufacturer
APNAR PHARMA LP | Apnar Pharma Private Limited | APNAR PHARMA LLP
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:26

Label at a glance#

ProductAcetaminophen,Caffeine and Pyrilamine Maleate
Active ingredientCAFFEINE, PYRILAMINE MALEATE, ACETAMINOPHEN
Label structure12 sections

Boxed warning

Caution: Do not use if imprinted seal under cap is broken or missing

Storage and handling

Other Information Store at 15° - 30°C (59° – 86° F).

Label contents#

Full prescribing information#

BOXED WARNING SECTION

Caution: Do not use if imprinted seal under cap is broken or missing

OTC - ACTIVE INGREDIENT SECTION

Drug facts

Active Ingredient (in each tablet)


Acetaminophen USP....... 500 mg

Caffeine USP....................60 mg

Pyrilamine Maleate USP......15 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/Diuretic/Antihistamine

INDICATIONS & USAGE SECTION

Use(s)

for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue

WARNINGS SECTION

Warnings:

Liver warning:

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

  • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin or severe allergy reactions. Symptoms may include:

  • Skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

Do not use:

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have:

  • liver disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

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

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if:

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever get worse or lasts more than 3 days

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

Overdose warning
In case of overdose, get medical help or contact a poison control center 1-800-222-1222 right away. Quick medical help attention is critical for adults as well as children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than the recommended dose
  • adults and children 12 years of age or older: take 2 tablets with water
  • repeat every 6 hours or as needed
  • do not exceed 6 tablets per day
  • children under 12 years: consult a doctor

STORAGE AND HANDLING SECTION

Other Information

  • Store at 15° - 30°C (59° – 86° F).

INACTIVE INGREDIENT SECTION

Inactive Ingredients

pregelatinized starch, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, talc

OTC - QUESTIONS SECTION

Questions or comments?

1-855-642-2594

SPL UNCLASSIFIED SECTION

Manufactured for:

Apnar Pharma LP

CHINO, CA, 91710

Rev.: 05/2022

†This product is not manufactured or distributed by Bayer Healthcare, LLC owner of the registered trademark Midol Complete®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APNAR PHARMA LP

NDC: 24689-121-01

Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets -20's Tablets

ACP tablet-20s tabletsACP tablet-20s tablets

APNAR PHARMA LP

NDC: 24689-121-02

Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets -500's Tablets

ACP tablets-500sACP tablets-500s

FDA-Initiated Inactive NDC Indexing#

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
24689-12124689-121-01, 24689-121-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
45d32473-7a94-266d-e063-6394a90a4810e2308622-0b91-3cb4-e053-2a95a90a61492025-12-13Boxed warning, WarningsExact identifier
spl set id: e2308622-0b91-3cb4-e053-2a95a90a6149

Reported adverse events (FAERS/openFDA)#

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