MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet tablet

Midol Complete by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Drug Facts

Uses

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

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

Warnings

Liver Warning

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.

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

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.

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

Other Information

store at room temperature

INACTIVE INGREDIENTS

carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

QUESTIONS OR COMMENTS?

1-800-331-4536 (Mon-Fri 9AM-5PM EST) or www.midol.com

Active Ingredient

• Active ingredients (in each caplet): Purpose
• Acetaminophen 500 mg: Pain reliever
• Caffeine 60 mg: Diuretic
• Pyrilamine maleate 15 mg: Antihistamine

PRINCIPAL DISPLAY PANEL- 2 Caplet Pouch Package

Midol ®
COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate
Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS BLOATING FATIGUE

HEADACHE BACKACHE

2
Caplets

PRINCIPAL DISPLAY PANEL-4 Caplet Pouch Package

Midol ®
COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate
Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS BLOATING FATIGUE

HEADACHE BACKACHE

4
Caplets

PRINCIPAL DISPLAY PANEL-25 Caplet Pouch Box

Midol ®
COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate
Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS BLOATING FATIGUE

HEADACHE BACKACHE

25 POUCHES 2 CAPLETS EACH

PRINCIPAL DISPLAY PANEL-30 Caplet Pouch Box

Midol ®
COMPLETE

Acetaminophen/Caffeine/Pyrilamine Maleate
Pain Reliever/Diuretic/Antihistamine

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS BLOATING FATIGUE

HEADACHE BACKACHE

30 POUCHES 2 CAPLETS EACH

INGREDIENTS AND APPEARANCE

MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-7358
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
TRIACETIN (UNII: XHX3C3X673)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 29485-7358-4	2 in 1 BLISTER PACK	05/07/2013	12/31/2024
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	05/07/2013	12/31/2024

MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-2802
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
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIACETIN (UNII: XHX3C3X673)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

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: 29485-2802-2	1 in 1 BLISTER PACK	06/29/2005	12/31/2024
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	06/29/2005	12/31/2024

MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-7964
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)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
TRIACETIN (UNII: XHX3C3X673)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 29485-7964-2	25 in 1 BOX	07/10/2020
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 29485-7964-3	30 in 1 BOX	10/19/2015
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 29485-7964-4	50 in 1 BOX	07/10/2020
3		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	10/19/2015

Labeler - Lil' Drug Store Products, Inc. (093103646)