Label: MENSTRUAL COMPLETE MAXIMUM STRENGTH- acetaminophen, caffeine, pyrilamine maleate tablet, film coated
- NDC Code(s): 63868-032-24
- Packager: CHAIN DRUG MARKETING ASSOCIATION 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.
Updated October 4, 2019
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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
- 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
- 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 beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
- 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.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
*Compare to the active ingredients
in MIDOL® COMPLETE
Acetaminophen 500 mg, Caffeine 60 mg
Pyrilamine maleate 15 mg
Pain Reliever / Diuretic / Antihistamine
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
Quality Choice 44-390
INGREDIENTS AND APPEARANCE
MENSTRUAL COMPLETE MAXIMUM STRENGTH
acetaminophen, caffeine, pyrilamine maleate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-032 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:63868-032-24 1 in 1 CARTON 04/29/2002 1 24 in 1 BOTTLE; 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 04/29/2002 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(63868-032) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(63868-032) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(63868-032) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(63868-032) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(63868-032)