MENSTRUAL COMPLETE GELCAPS- acetaminophen, caffeine, pyrilamine maleate tablet, coated

Menstrual Complete Gelcaps by

Drug Labeling and Warnings

Menstrual Complete Gelcaps by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gelcap)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purposes

Pain reliever
Diuretic
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 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:  hives  blisters  rash  skin reddening  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, ask a health professional before use

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as 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 gelcaps with water  repeat every 6 hours as needed  do not exceed 6 gelcaps per day
 children under 12 years: consult a doctor

Other information

each gelcap contains: sodium 3 mg (very low sodium)
Store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive ingredients

croscarmellose sodium, D&C red #33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone K30, pregelatinized starch, purified water, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

Questions or comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to active ingredients of Midol® Complete*

DG™ health

Multi-Symptom Relief of:
Cramps    Bloating
 Fatigue    Backache
Headache

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol®.

DISTRIBUTED BY: OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

PRODUCT OF UNITED ARAB EMIRATES

Packaging

INGREDIENTS AND APPEARANCE

MENSTRUAL COMPLETE GELCAPS 
acetaminophen, caffeine, pyrilamine maleate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-960
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, POTATO (UNII: 8I089SAH3T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	blue	Score	no score
Shape	RECTANGLE	Size	18mm
Flavor		Imprint Code	S79
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-960-24	3 in 1 CARTON	01/25/2023
1		8 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	01/25/2023

Labeler - Dolgencorp Inc (068331990)