FLO PMS COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet

FLO PMS Complete by

Drug Labeling and Warnings

FLO PMS Complete by is a Otc medication manufactured, distributed, or labeled by O Positiv, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses

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

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.

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.

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

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

SPL UNCLASSIFIED SECTION

Maximum Strength 

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

OPOSITIV.COM
Distributed By: O Positiv, Inc.
11740 San Vicente Blvd Los Angeles, CA 90049

Packaging

INGREDIENTS AND APPEARANCE

FLO PMS COMPLETE 
acetaminophen, caffeine, pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83049-489
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	FLO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83049-489-08	3 in 1 CARTON	12/05/2022
1		8 in 1 BLISTER PACK; 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	12/05/2022

Labeler - O Positiv, Inc. (107922667)