Label: MENSTRUAL COMPLETE MAXIMUM STRENGTH- acetaminophen, caffeine and pyrilamine maleate tablet, film coated
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- NDC Code(s): 50844-390-19, 50844-390-21
- Packager: L.N.K. International, 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 November 11, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 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.
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
- glaucoma
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
- be careful when driving a motor vehicle or operating machinery
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- 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 appear
- redness or swelling is present
- pain gets worse or lasts more than 10 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- do not take more than the recommended dose (see Overdose warning)
- adults and children 12 years and older: take 2 caplets with water. Repeat every 6 hours, as needed. Do not exceed 8 caplets in 24 hours.
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
QUALITY PLUS
NDC 50844-390-21
*Compare to the active ingredients in Midol® Complete
MAXIMUM STRENGTH
Menstrual Complete
Acetaminophen, Caffeine, Pyrilamine maleate
PAIN RELIEVER / STIMULANT / DIURETIC
MULTI-SYMPTOM RELIEF OF:
Cramps, Bloating, Fatigue,
Backache & Headache16 Caplets
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
50844 ORG081039021
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Quality Plus 390-21
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INGREDIENTS AND APPEARANCE
MENSTRUAL COMPLETE MAXIMUM STRENGTH
acetaminophen, caffeine and pyrilamine maleate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-390 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) HYPROMELLOSE, UNSPECIFIED (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) CROSPOVIDONE (UNII: 2S7830E561) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:50844-390-19 1 in 1 CARTON 04/29/2002 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50844-390-21 2 in 1 CARTON 04/29/2002 2 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 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(50844-390) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(50844-390) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(50844-390) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(50844-390) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(50844-390)