Label: MENSTRUAL COMPLETE GELCAPS- acetaminophen, caffeine, pyrilamine maleate tablet, coated
- NDC Code(s): 55910-960-24
- Packager: Dolgencorp Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 13, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each gelcap)
- Purposes
- Uses
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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: • 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 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
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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
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SPL UNCLASSIFIED SECTION
Compare to active ingredients of Midol® Complete*
DG™ health
Multi-Symptom Relief of:
• Cramps • Bloating
• Fatigue • Backache
• HeadacheREAD 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
- Packaging
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INGREDIENTS AND APPEARANCE
MENSTRUAL COMPLETE GELCAPS
acetaminophen, caffeine, pyrilamine maleate tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-960 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) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) STARCH, POTATO (UNII: 8I089SAH3T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color blue Score no score Shape RECTANGLE Size 18mm Flavor Imprint Code S79 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-960-24 3 in 1 CARTON 01/25/2023 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 01/25/2023 Labeler - Dolgencorp Inc (068331990)