MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet

Menstrual Complete by

Drug Labeling and Warnings

Menstrual Complete by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gelcap)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purposes

Pain reliever
Diuretic
Antihistamine

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 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: 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 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

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as 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 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

Other information

each gelcap contains sodium 3 mg store at room temperature.

Inactive ingredients

croscarmellose sodium, D&C red#33 aluminium lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, Isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water,  PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

Questions or comments?

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

SPL UNCLASSIFIED SECTION

RIGHT REMEDIES

Compare to the active ingredients in Midol®​ Complete*

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.  DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BRPKEN OR MISSING

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

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of United Arab Emirates

Packaging

INGREDIENTS AND APPEARANCE

MENSTRUAL COMPLETE 
acetaminophen, caffeine, pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-131
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, POTATO (UNII: 8I089SAH3T)
WATER (UNII: 059QF0KO0R)
POVIDONE K30 (UNII: U725QWY32X)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	blue (Dark and Light Blue)	Score	no score
Shape	OVAL (oblong)	Size	18mm
Flavor		Imprint Code	S79
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-131-24	3 in 1 CARTON	04/05/2023
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70692-131-46	72 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/05/2023

Labeler - Strive Pharmaceuticals Inc. (080028013)