Label: MENSTRUAL COMPLETE MAXIMUM STRENGTH- acetaminophen, caffeine and pyrilamine maleate tablet, film coated
- NDC Code(s): 37205-738-62
- Packager: CARDINAL HEALTH
- 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 November 6, 2018
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- Active ingredients (in each caplet)
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
- 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
- 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 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.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Other information
- Inactive ingredients
Principal Display Panel
M en s t r u a l C o m p l e t e
Acetaminophen, Caffeine, Pyrilamine maleate
Pain Reliever • Diuretic • Antihistamine
Cramps • Bloating • Fatigue • Backache • Headache
*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
INGREDIENTS AND APPEARANCE
MENSTRUAL COMPLETE MAXIMUM STRENGTH
acetaminophen, caffeine and pyrilamine maleate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-738 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) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score score with uneven pieces Shape OVAL Size 17mm Flavor Imprint Code 44;390 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-738-62 3 in 1 CARTON 04/29/2002 10/16/2020 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 04/29/2002 10/16/2020 Labeler - CARDINAL HEALTH (097537435) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(37205-738) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(37205-738) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(37205-738) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(37205-738) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(37205-738)