Menstrual Complete

Menstrual Complete
SPL v5
SPL
SPL Set ID 8c44ee8e-8856-472b-8fef-e3be9cb1148c
Route
ORAL
Published
Effective Date 2023-06-05
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
Croscarmellose Sodium D&c Red No. 33 Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Gelatin, Unspecified Glycerin Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone K30 Starch, Potato Water Sorbitol Sorbitan Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-25

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

Uses

for the temporary relief of these symptoms associated with menstrual periods: • cramps • bloating • water-weight gain • headache • backache • muscle aches • fatigue

Section 42229-5

Compare to active ingredients of  Midol®  Complete*

DG™ health

Multi-Symptom Relief of:

• Cramps    • Bloating

• Fatigue    • Backache

• Headache

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER  UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol®.

DISTRIBUTED BY: OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

PRODUCT OF UNITED ARAB EMIRATES

Section 50565-1

Keep out of reach of children.

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

Purposes

Pain reliever

Diuretic

Antihistamine

Warnings

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

• more than 6 gelcaps 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 allergic reactions.

Symptoms may include: • hives • blisters • rash • skin reddening • 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 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 gets worse or lasts more than 3 days

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

Packaging

Directions

• do not take more than the recommended dose

• adults and children 12 years and older: take 2 gelcaps with water • repeat every 6 hours as needed • do not exceed 6 gelcaps per day

• children under 12 years: consult a doctor

Drug Facts

Other Information

each gelcap contains: sodium 3 mg (very low sodium)

Store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

croscarmellose sodium, D&C red #33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone K30, pregelatinized starch, purified water, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredients (in Each Gelcap)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg


Structured Label Content

Uses

for the temporary relief of these symptoms associated with menstrual periods: • cramps • bloating • water-weight gain • headache • backache • muscle aches • fatigue

Section 42229-5 (42229-5)

Compare to active ingredients of  Midol®  Complete*

DG™ health

Multi-Symptom Relief of:

• Cramps    • Bloating

• Fatigue    • Backache

• Headache

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER  UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol®.

DISTRIBUTED BY: OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

PRODUCT OF UNITED ARAB EMIRATES

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purposes

Pain reliever

Diuretic

Antihistamine

Warnings

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

• more than 6 gelcaps 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 allergic reactions.

Symptoms may include: • hives • blisters • rash • skin reddening • 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 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 gets worse or lasts more than 3 days

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

Packaging

Directions

• do not take more than the recommended dose

• adults and children 12 years and older: take 2 gelcaps with water • repeat every 6 hours as needed • do not exceed 6 gelcaps per day

• children under 12 years: consult a doctor

Drug Facts

Other Information (Other information)

each gelcap contains: sodium 3 mg (very low sodium)

Store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C red #33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone K30, pregelatinized starch, purified water, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredients (in Each Gelcap) (Active ingredients (in each gelcap))

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)