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Midol Complete Gelcaps

Medically reviewed on November 13, 2017

Dosage form: tablet, coated
Ingredients: CAFFEINE 60mg, PYRILAMINE MALEATE 15mg, ACETAMINOPHEN 500mg
Labeler: Bayer HealthCare LLC
NDC Code: 0280-8015

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.

Midol Complete Gelcaps

Drug Facts

Active ingredients (in each gelcap) Purpose

Acetaminophen 500 mg..............................………………….Pain reliever

Caffeine 60 mg……….…………………………………….……..….Diuretic

Pyrilamine maleate 15 mg……………………………………Antihistamine

Purpose

Uses for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle ache
  • fatigue

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

· 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.

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

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

· do not take more than the recommended dose

· adults and children 12 years and older:

· take 2 gelcaps with water

· repeat every 6 hours, as needed

· do not exceed 6 gelcaps per day

· children under 12 years: consult a doctor

Other information

· store at room temperature

· avoid excessive heat 104°F (40°C)

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

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

MIDOL COMPLETE  GELCAPS
midol complete tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-8015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE60 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE15 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
ALUMINUM OXIDE 
EDETATE DISODIUM 
FERROSOFERRIC OXIDE 
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
Product Characteristics
ColorturquoiseScoreno score
ShapeOVALSize10mm
FlavorImprint CodeMIDOL
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-8015-243 BLISTER PACK in 1 CARTON
124 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/15/2014
Labeler - Bayer HealthCare LLC (112117283)

 
Bayer HealthCare LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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