Label: MENSTRUAL RELIEF MAXIMUM STRENGTH- acetaminophen, caffeine and pyrilamine maleate tablet
- NDC Code(s): 0363-0252-10, 0363-0252-21
- Packager: Walgreen Company
- 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 February 11, 2019
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- Active ingredients (in each caplet)
Acetaminophen 500 mgClose
Caffeine 60 mg
Pyrilamine maleate 15 mg
for the temporary relief of these symptoms associated with menstrual periods:
- water-weight gain
- muscle aches
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
- 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
- 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.
- avoid alcoholic beverages
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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than the recommended dose
- adults and children 12 years and over:
- take 2 caplets with water
- repeat every 6 hours, as needed
- do not exceed 6 caplets per day
- children under 12 years: ask a doctor
- Other information
- see end flap for expiration date and lot number
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetinClose
- Questions or comments?
- Principal Display Panel
Compare to Midol® Complete
ACETAMINOPHEN 500 mg / PAIN RELIEVER
CAFFEINE 60 mg / DIURETIC
PYRILAMINE MALEATE 15 mg / ANTIHISTAMINE
MAXIMUM STRENGTH ASPIRIN FREE
• Relieves cramps, bloating, fatigue, headaches & backaches
ǂǂThis product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2017 Walgreen Co.
- INGREDIENTS AND APPEARANCE
MENSTRUAL RELIEF MAXIMUM STRENGTH
acetaminophen, caffeine and pyrilamine maleate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0252 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) 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:0363-0252-21 2 in 1 CARTON 04/29/2002 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-0252-10 1 in 1 CARTON 04/29/2002 2 40 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 04/29/2002 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0252) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-0252) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0363-0252) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(0363-0252) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(0363-0252)