MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet

Midol Complete by

Drug Labeling and Warnings

Midol Complete by is a Otc medication manufactured, distributed, or labeled by Select Consumer Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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

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 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

PRINCIPAL DISPLAY PANEL - 30 pouches of 2 caplets

Midol ®

Complete

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MAXIMUM STRENGTH

MULTI-SYMPTOM

RELIEF OF

CRAMPS, BLOATING

FATIGUE, BACKACHE

& HEADACHE

40 CAPLETS

Package / Label Principal Display 2 caplet pack

Midol ®

Complete

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MAXIMUM STRENGTH

MULTI-SYMPTOM

RELIEF OF

CRAMPS, BLOATING

FATIGUE, BACKACHE

& HEADACHE

2 caplet pack

Principal Package / Label display panel 4 caplets Multipack

Midol ®

Complete

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MAXIMUM STRENGTH

MULTI-SYMPTOM

RELIEF OF

CRAMPS, BLOATING

FATIGUE, BACKACHE

& HEADACHE

4 CAPLETS

Package / Label Principal DIsplay Panel 25 Pouches of 2 caplets

Midol ®

Complete

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MAXIMUM STRENGTH

MULTI-SYMPTOM

RELIEF OF

CRAMPS, BLOATING

FATIGUE, BACKACHE

& HEADACHE

25 Pouches of 2 caplets

Package / Label Principal Display Panel 20 pack of 2 caplets

Midol ®

Complete

Acetaminophen/Caffeine/Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

MAXIMUM STRENGTH

MULTI-SYMPTOM

RELIEF OF

CRAMPS, BLOATING

FATIGUE, BACKACHE

& HEADACHE

20 Pouches of 2 caplets

INGREDIENTS AND APPEARANCE

MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85237-1841(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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (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: 85237-1841-1	1 in 1 BLISTER PACK	02/10/2014
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 85237-1841-2	2 in 1 BLISTER PACK	02/10/2014
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 85237-1841-3	20 in 1 BOX, UNIT-DOSE	02/10/2014
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 85237-1841-4	25 in 1 BOX, UNIT-DOSE	02/10/2014
4		2 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 85237-1841-5	30 in 1 BOX, UNIT-DOSE	02/10/2014
5		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	M027	02/10/2014

Labeler - Select Consumer Group (119185084)

Registrant - Select Consumer Group (119185084)

Establishment
Name	Address	ID/FEI	Business Operations
Select Consumer Group		119185084	repack(85237-1841)