470 - Menstrual Complete

470 - Menstrual Complete
SPL v2
SPL
SPL Set ID d197b886-67e4-4aba-8582-305576c07604
Route
ORAL
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (60 mg) Pyrilamine (15 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Crospovidone Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Povidone Silicon Dioxide Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;390 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-05

Description

Acetaminophen 500 mg  Caffeine 60 mg  Pyrilamine maleate 15 mg 

Purpose

Pain reliever Diuretic Antihistamine


Medication Information

Purpose

Pain reliever

Diuretic

Antihistamine

Description

Acetaminophen 500 mg  Caffeine 60 mg  Pyrilamine maleate 15 mg 

Use(s)

for the temporary relief of these symptoms associated

with menstrual periods:

■ water-weight gain ■ backache ■ muscle aches

■ cramps ■ fatigue ■ headache ■ bloating

Warnings

Liver warning: This product contains acetaminophen. Severe liver

damage may occur if you take

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: ■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions

■ do not take more than directed

■ 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: ask a doctor

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

Other Information

■ store at 25°C (77°F); excursions permitted between

15°-30°C (59°-86°F) ■ use by expiration date on package

Questions/comments

1-888-952-0050

Active Ingredient(s)

Acetaminophen 500 mg 

Caffeine 60 mg 

Pyrilamine maleate 15 mg 

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone,

hypromellose, magnesium stearate, microcrystalline

cellulose, polydextrose, polyethylene glycol, povidone, silicon

dioxide, stearic acid, titanium dioxide, triacetin

Principal Display Panel
Menstrual Complete
When Using This Product

■ drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase

drowsiness ■ avoid alcoholic beverages

■ excitability may occur, especially in children

■ use caution when driving a motor vehicle or operating

machinery

■ limit the use of caffeine-containing medications, foods, or

beverages while taking this product because too much

caffeine may cause nervousness, irritability, sleeplessness,

and, occasionally, rapid heart rate. The recommended dose

of this product contains about as much caffeine as a cup of

coffee.

Ask A Doctor Before Use If

you have

■ difficulty in urination due to enlargement of the prostate

gland ■ liver disease ■ glaucoma

■ a breathing problem such as emphysema or chronic

bronchitis

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 gets worse or lasts more than 3 days

These could be signs of a serious condition.

If Pregnant Or Breastfeeding,

a health professional before use.

Keep Out of Reach of Children

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

Prompt medical attention is critical for adults as well as for

children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use If

you are

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers


Structured Label Content

Use(s)

for the temporary relief of these symptoms associated

with menstrual periods:

■ water-weight gain ■ backache ■ muscle aches

■ cramps ■ fatigue ■ headache ■ bloating

Purpose

Pain reliever

Diuretic

Antihistamine

Warnings

Liver warning: This product contains acetaminophen. Severe liver

damage may occur if you take

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: ■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions

■ do not take more than directed

■ 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: ask a doctor

Do Not Use (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

Other Information (Other information)

■ store at 25°C (77°F); excursions permitted between

15°-30°C (59°-86°F) ■ use by expiration date on package

Questions/comments (Questions/Comments)

1-888-952-0050

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 500 mg 

Caffeine 60 mg 

Pyrilamine maleate 15 mg 

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, crospovidone,

hypromellose, magnesium stearate, microcrystalline

cellulose, polydextrose, polyethylene glycol, povidone, silicon

dioxide, stearic acid, titanium dioxide, triacetin

Principal Display Panel
Menstrual Complete
When Using This Product (When using this product)

■ drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase

drowsiness ■ avoid alcoholic beverages

■ excitability may occur, especially in children

■ use caution when driving a motor vehicle or operating

machinery

■ limit the use of caffeine-containing medications, foods, or

beverages while taking this product because too much

caffeine may cause nervousness, irritability, sleeplessness,

and, occasionally, rapid heart rate. The recommended dose

of this product contains about as much caffeine as a cup of

coffee.

Ask A Doctor Before Use If (Ask a doctor before use if)

you have

■ difficulty in urination due to enlargement of the prostate

gland ■ liver disease ■ glaucoma

■ a breathing problem such as emphysema or chronic

bronchitis

Stop Use and Ask A Doctor If (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 gets worse or lasts more than 3 days

These could be signs of a serious condition.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

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

Prompt medical attention is critical for adults as well as for

children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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