Label: MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet
- NDC Code(s): 0280-8005-16, 0280-8005-24, 0280-8005-40
- Packager: Bayer HealthCare 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 November 7, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Caffeine 60 mg Diuretic Pyrilamine maleate 15 mg Antihistamine
for the temporary relief of these symptoms associated with menstrual periods:
- water-weight gain
- muscle aches
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount for this product
- 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
- 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 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 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
Keep out of reach of children. 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.
- do not take more than the recommended dose
- adults and children 12 years and older:
- take 2 caplets with water
- repeat every 6 hours, as needed
- do not exceed 6 caplets per day
- children under 12 years: consult a doctor
- Other information
store at room temperatureClose
- Inactive ingredients
carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetinClose
- Questions or comments?
1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or www.midol.comClose
- PRINCIPAL DISPLAY PANEL - 40 Caplet Bottle Carton
- INGREDIENTS AND APPEARANCE
acetaminophen, caffeine, and pyrilamine maleate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-8005 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape OVAL (oblong) Size 17mm Flavor Imprint Code MIDOL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-8005-16 2 in 1 CARTON 02/10/2014 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0280-8005-24 3 in 1 CARTON 02/10/2014 2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0280-8005-40 1 in 1 CARTON 02/10/2014 3 40 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 02/10/2014 Labeler - Bayer HealthCare LLC. (112117283)