BUSCAPINA- acetaminophen, caffeine, pyrilamine maleate tablet, coated

Buscapina by

Drug Labeling and Warnings

Buscapina by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Vovantis Laboratories Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

PURPOSE

Purpose

Acetaminophen 500 mg . . . . . . . . . . Pain reliever

Caffeine 60 mg . . . . . . . . . . . . . . . . . Diuretic

Pyrilamine Maleate 15 mg . . . . . . . . Antihistamine

INDICATIONS & USAGE

Uses

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. Sever liber damage may occur if you take:

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

Allergy alert:

acetaminophen may cause severe skin or severe allergic reactions, Symptoms may include:

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

If a skin or general allergic reactions 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 have ever had an allertgic 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 appear
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days

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

Keep out of reach of chlidren.

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.

DOSAGE & ADMINISTRATION

Directions

• do not exceed recommended dosage
• adults and children 12 years and over:
• take 2 caplets with water. Repeat every 6 hours, as needed.
• do not exceed 6 caplets per day
  • children under 12 years: consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 68-77°F (20-25°C)
• TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

INACTIVE INGREDIENT

Inactive ingredients

Colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

QUESTIONS

Questions or comments?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

Principal Display Panel - Buscapina 144 Caplets

Buscapina

Acetaminophen, Caffeine, Pyrilamine Maleate Tablets

NDC: 69729-131-72

Acetaminophen 500 mg . . . . . . . Pain reliever

Caffeine 60 mg . . . . . . . . . . . . . . Diuretic

Pyrilamine Maleate 15 mg . . . . . Antihistamine

• Cramps / Colicos
• Bloating / Hinchzon
• Fatigue / Fatiga
• Heacache

Dolor de Cabeza

• Backache

Dolor de Espalda

144 Caplets

72 packs of 2 Caplets

Made in India

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

Principal Display Panel - Buscapina 100 Caplets

NDC: 69729-131-50

Buscapina

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Pain Reliever

Cramps/Cólicos

Bloating/Hinchazón

Fatigue/Fatiga

Headache/Dolor de Cabeza

Backache/Dolor de Espalda

100 Caplets/ 50 packs of 2 Caplets

INGREDIENTS AND APPEARANCE

BUSCAPINA 
acetaminophen, caffeine, pyrilamine maleate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-131
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE (UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	V1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-131-72	72 in 1 CARTON	06/06/2022
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69729-131-50	50 in 1 CARTON	12/05/2023
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/06/2022

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Vovantis Laboratories Private Limited		650502151	manufacture(69729-131)