Label: MENSTRUAL COMPLETE GELCAPS- acetaminophen, caffeine, pyrilamine maleate tablet, coated
- NDC Code(s): 55910-960-24
- Packager: Dolgencorp Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 22, 2023
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
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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 not final part343 01/25/2023 Labeler - Dolgencorp Inc (068331990)