Label: MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet
- NDC Code(s): 70264-012-01
- Packager: R J General Corporation
- This is a repackaged label.
- Source NDC Code(s): 0280-8005
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
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.
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
- 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.
Directions
- 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.
Ask a doctor before use if you have
- liver disease.
- glaucoma.
- 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.
- DOSAGE & ADMINISTRATION
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 100 Caplet Pouch Carton
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INGREDIENTS AND APPEARANCE
MIDOL COMPLETE
acetaminophen, caffeine, and pyrilamine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70264-012(NDC:0280-8005) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TRIACETIN (UNII: XHX3C3X673) CARNAUBA WAX (UNII: R12CBM0EIZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) SHELLAC (UNII: 46N107B71O) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code MIDOL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70264-012-01 50 in 1 CARTON 10/02/2014 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/10/2014 Labeler - R J General Corporation (122542830) Establishment Name Address ID/FEI Business Operations R J General Corporation 122542830 repack(70264-012)
