MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet

Menstrual Complete by

Drug Labeling and Warnings

Menstrual Complete by is a Otc medication manufactured, distributed, or labeled by The Kroger Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Purpose

Pain reliever

Diuretic

Antihistamine

Uses

• for the temporary relief of these symptoms associated with menstrual periods
  • cramps
  • bloating
  • fatigue
  • backache 
  • water-weight gain
  • headache 
  • muscle aches

Warnings

 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
• blisters
• rash

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 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

• drowsiness may occur
• 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 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 take more than 6 caplets in 24 hours
• children under 12 years: consult a doctor

Other information

• store at 25ºC (77ºF) excursions permitted between 15º- 30ºC (59º- 86ºF)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of MIDOL® COMPLETE  *See bottom panel

Menstrual Complete

Acetaminophen 500 mg, Pain Reliever

Caffeine 60 mg, Diuretic

Pyrilamine maleate 15 mg, Antihistamine

Maximum Strength

Multi-Symptom Relief Of:

• Cramps
• Bloating
• Fatigue
• Backache & Headache

CAPLETS

*Midol® is a registered trademark of Bayer Healthcare LLC, Tarrytown, NY, 10591-5124. Bayer Healthcare LLC is not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Kroger Menstrual Complete Caplets

INGREDIENTS AND APPEARANCE

MENSTRUAL COMPLETE 
acetaminophen, caffeine, pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-181
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)
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)
CROSPOVIDONE (UNII: 2S7830E561)

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: 30142-181-48	1 in 1 BOX	03/28/2014
1		48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 30142-181-40	1 in 1 BOX	03/28/2014
2		40 in 1 BOTTLE, PLASTIC; 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	03/28/2014

Labeler - The Kroger Co. (006999528)