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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Buscapina

Active Ingredients (in each caplet)

Acetaminophen 500mg, Caffeine 60mg, and Pyrilamine maleate 15mg 

Purpose

Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

Uses

• For the temporary relief of these symptoms associated with menstrual periods
• Cramps
• Bloating
• Water- weight gain
• Headache
• Backache
• Muscle aches
• Fatigue

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 warning: 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 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 have 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 aboout 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 children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

• Do not exceed recommended dosage.
• Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
• Children under 12 years: Consult a doctor

Other Information

• Store at room temperature
• TAMPER EVIDENT; DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

• Colloidal silicon dioxide
• Hypromellose
• Magnesium stearate
• Microcrystalline cellulose
• Polyethylene glycol
• Polyvinyl pyrrolidone
• Pregelatinized starch
• Titanium dioxide
• Talc

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM or www.healthlifeofusa.com

BuscapinaAcetaminophen 500mgCaffeine 60mgPyrilamine maleate 15mg24 CapletsDistributed By:OPMXSan Diego, CA, 92154

INGREDIENTS AND APPEARANCE

BUSCAPINA 
acetaminophen, caffeine, pyrilamine maleate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-130
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	17mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-130-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/05/2018

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Limited		915664486	manufacture(69729-130)