MIDOL COMPLETE GELCAPS- midol complete tablet, coated

Midol Complete by

Drug Labeling and Warnings

Midol Complete by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gelcap) Purpose

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

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

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

Purpose

INDICATIONS & USAGE

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

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

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

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 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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
· taking the blood thinning drug warfarin
· taking sedatives or tranquilizers

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

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

· store at room temperature

· avoid excessive heat 104°F (40°C)

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIDOL COMPLETE  GELCAPS
midol complete tablet, coated

Product 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 not final	part343	12/15/2014

Labeler - Bayer HealthCare LLC (112117283)