Label: MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet, film coated
- NDC Code(s): 36800-391-08
- Packager: Topco Associates, LLC
- 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.
Updated October 27, 2020
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- Active ingredients (in each caplet)
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
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
- 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
- avoid alcoholic beverages
- 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.
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.
- more than 4,000 mg of acetaminophen in 24 hours
- Other information
- Inactive ingredients
- Questions or comments?
Principal display panel
COMPARE TO MIDOL® COMPLETE ACTIVE INGREDIENTS*
ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
PAIN RELIEVER • DIURETIC • ANTIHISTAMINE
MULTI-SYMPTOM RELIEF OF:
• Cramps • Headache • Bloating
• Backache • Fatigue
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL
INGREDIENTS AND APPEARANCE
acetaminophen, caffeine, pyrilamine maleate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-391 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 (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color WHITE Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;390 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-391-08 1 in 1 CARTON 01/01/2019 1 24 in 1 BOTTLE, PLASTIC; 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 01/01/2019 Labeler - Topco Associates, LLC (006935977) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(36800-391) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(36800-391) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(36800-391) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(36800-391) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(36800-391)