Flo®

Flo®
SPL v4
SPL
SPL Set ID cce62d9f-adb1-4473-8258-910dff6b1378
Route
ORAL
Published
Effective Date 2022-12-20
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, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-05

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

Uses

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

• bloating   • headache  • muscle aches

• cramps    • backache   • fatigue

• water-weight gain

Section 42229-5

Maximum Strength 

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

OPOSITIV.COM

Distributed By: O Positiv, Inc.

11740 San Vicente Blvd Los Angeles, CA 90049

Section 50565-1

Keep out of reach of children. In case of accidental 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.

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.

Do not use • if you have ever had an allergic reaction to this product or any of its ingredients 

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

When using this product 

• excitability may occur, especially in children 

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness  • you may get drowsy

• 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 heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

• avoid alcoholic beverages

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 breast-feeding, ask a health professional before use.

Packaging

Directions

do not take more than the recommended dose

• 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

Drug Facts

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

• see end flap for expiration date and lot number

• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions Or Comments?

1-800-426-9391

Active Ingredients (in Each Caplet)

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:

• bloating   • headache  • muscle aches

• cramps    • backache   • fatigue

• water-weight gain

Section 42229-5 (42229-5)

Maximum Strength 

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

OPOSITIV.COM

Distributed By: O Positiv, Inc.

11740 San Vicente Blvd Los Angeles, CA 90049

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental 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.

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.

Do not use • if you have ever had an allergic reaction to this product or any of its ingredients 

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

When using this product 

• excitability may occur, especially in children 

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness  • you may get drowsy

• 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 heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

• avoid alcoholic beverages

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 breast-feeding, ask a health professional before use.

Packaging

Directions

do not take more than the recommended dose

• 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

Drug Facts

Other Information (Other information)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

• see end flap for expiration date and lot number

• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)