Label: MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet
- NDC Code(s): 70692-131-24, 70692-131-46
- Packager: Strive Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each gelcap)
- Purposes
- Uses
-
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 productAllergy 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 ingredientsAsk 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 bronchitisAsk a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizersWhen 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 daysIf pregnant or breast-feeding, ask a health professional before use
- Directions
- Other information
-
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?
-
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 tabletProduct 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)