Label: COMPLETE MENSTRUAL RELIEF- acetaminophen, caffeine, pyrilamine maleate tablet
- NDC Code(s): 50804-183-24
- Packager: Good Sense (Geiss, Destin & Dunn, Inc.)
- 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 December 20, 2019
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- Active ingredients (in each caplet)
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 ingredient
Ask a doctor before use if you have
- liver disease
- difficulty in urination due to an 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
- drowsiness may occur
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol,sedative, 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
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Menstrual Relief Caplets
Acetaminophen, Caffeine, Pyrilamine maleate
- Pain Reliever
Multi-Symptom Relief of:
- Backache & Headache
*Compare to active ingredients in Midol® Complete
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
*This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Midol® Complete.
Distributed by: Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
- Package Labeling
INGREDIENTS AND APPEARANCE
COMPLETE MENSTRUAL RELIEF
acetaminophen, caffeine, pyrilamine maleate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-183 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code TCL347 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-183-24 2 in 1 BOX 01/16/2012 12/30/2021 1 12 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 NOT FINAL part343 01/16/2012 12/30/2021 Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)