Label: MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-841-04, 52904-841-20, 52904-841-25, 52904-841-30 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 0280-8005
- 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 April 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Blister Pack
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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:52904-841(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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) microcrystalline cellulose (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:52904-841-04 1 in 1 BLISTER PACK 02/10/2014 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-841-20 20 in 1 CARTON 02/10/2014 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:52904-841-25 25 in 1 CARTON 02/10/2014 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:52904-841-30 30 in 1 CARTON 02/10/2014 4 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 NOT FINAL part343 02/10/2014 Labeler - Select Corporation (053805599)
