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NDC 30142-0181-48 Menstrual Complete 500; 60; 15 mg/1; mg/1; mg/1 Details

Menstrual Complete 500; 60; 15 mg/1; mg/1; mg/1

Menstrual Complete is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by The Kroger Co.. The primary component is ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE.

Product Information

NDC	30142-0181
Product ID	30142-181_45ed917a-f08f-41c9-8034-625e32efa2b6
Associated GPIs
GCN Sequence Number	020181
GCN Sequence Number Description	acetaminophen/pyrilamine/caff TABLET 500-15-60 ORAL
HIC3	B5Y
HIC3 Description	ANALGESIC,NON-SALICYLATE-1ST GEN ANTIHIST-XANTHINE
GCN	72751
HICL Sequence Number	008260
HICL Sequence Number Description	ACETAMINOPHEN/PYRILAMINE MALEATE/CAFFEINE
Brand/Generic	Generic
Proprietary Name	Menstrual Complete
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Caffeine, Pyrilamine maleate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500; 60; 15
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Labeler Name	The Kroger Co.
Pharmaceutical Class	Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 30142-0181-48 (30142018148)

Pricing Information	N/A
NDC Package Code	30142-181-48
Billing NDC	30142018148
Package	1 BOTTLE, PLASTIC in 1 BOX (30142-181-48) / 48 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2014-03-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 49649091-187c-4c7d-b063-57aa4ae402ee Details

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

Acetaminophen 500 mg Caffeine 60 mg Pyrilamine Maleate 15 mg

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-181-40	1 in 1 BOX	03/28/2014	02/23/2024
1		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:30142-181-48	1 in 1 BOX	03/28/2014	02/23/2024
2		48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/28/2014	02/23/2024

Labeler - The Kroger Co. (006999528)

Revised: 11/2021

Document Id: 45ed917a-f08f-41c9-8034-625e32efa2b6

Set id: 49649091-187c-4c7d-b063-57aa4ae402ee

Version: 5

Effective Time: 20211108