Label: MIDOL COMPLETE GELCAPS- midol complete tablet, coated
- NDC Code(s): 0280-8015-24
- Packager: Bayer HealthCare LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 30, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- Purpose
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take· more than 6 gelcaps 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
Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
· skin reddening · blisters · rash
· hives · facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
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WHEN USING
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIDOL COMPLETE GELCAPS
midol complete tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-8015 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) ALUMINUM OXIDE (UNII: LMI26O6933) EDETATE DISODIUM (UNII: 7FLD91C86K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color turquoise Score no score Shape OVAL Size 10mm Flavor Imprint Code MIDOL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-8015-24 3 in 1 CARTON 12/15/2014 1 24 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 Drug M027 12/15/2014 Labeler - Bayer HealthCare LLC (112117283)