ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE tablet

Acetaminophen,Caffeine and Pyrilamine Maleate by

Drug Labeling and Warnings

Acetaminophen,Caffeine and Pyrilamine Maleate by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, Apnar Pharma Private Limited, APNAR PHARMA LLP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

(What is this?)

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

ACTIVE INGREDIENT

Drug facts

Active Ingredient (in each tablet)

Acetaminophen USP....... 500 mg

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

Pyrilamine Maleate USP......15 mg

PURPOSE

Purpose

Pain reliever/Diuretic/Antihistamine

INDICATIONS & USAGE

Use(s)

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

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

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

Other Information

• Store at 15° - 30°C (59° – 86° F).

INACTIVE INGREDIENT

Inactive Ingredients

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

QUESTIONS

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®

PRINCIPAL DISPLAY PANEL

APNAR PHARMA LP

NDC: 24689-121-01

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

APNAR PHARMA LP

NDC: 24689-121-02

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE 
acetaminophen,caffeine and pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	LT16
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-121-01	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2022
2	NDC: 24689-121-02	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/05/2022

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
Apnar Pharma Private Limited		876730408	analysis(24689-121) , manufacture(24689-121)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	pack(24689-121) , label(24689-121)