MENSTRUAL RELIEF- acetaminophen, caffeine, pyrilamine maleate tablet, film coated
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CVS 44-390

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:

bloating
headache
muscle aches
cramps
backache
fatigue
water-weight gain

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

if you have ever had an allergic reaction to this product or any of its ingredients
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

difficulty in urination due to enlargement of the prostate gland
liver disease
glaucoma
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

excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
you may get drowsy
limit the use of caffeine-containing medications, foods, or beverages while taking this product 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.
avoid alcoholic beverages

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 over:
- take 2 caplets with water
- repeat every 6 hours, as needed
- do not exceed 6 caplets per day
children under 12 years: ask a doctor

Other information

see end flap for expiration date and lot number
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVS
Health®

Compare to the active ingredients in Midol® Complete*

MAXIMUM STRENGTH

Menstrual Relief
ACETAMINOPHEN
CAFFEINE / PYRILAMINE MALEATE
Pain reliever, Diuretic, Antihistamine

MENSTRUAL
COMPLETE

Maximum strength
relief of:
• Cramps
• Bloating
• Fatigue
• Backache
& headache

24 CAPLETS

Actual Size

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

*This product is not manufactured or distributed by Beyer HealthCare LLC, owner of the registered trademark Midol® Complete.
50844 ORG051739008

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2021 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-11112

CVS Health 44-390

MENSTRUAL RELIEF
acetaminophen, caffeine, pyrilamine maleate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-930
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;390
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59779-930-08	3 in 1 CARTON	04/29/2002
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:59779-930-21	2 in 1 CARTON	04/29/2002
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:59779-930-10	1 in 1 CARTON	04/29/2002
3		40 in 1 BOTTLE; 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	04/29/2002

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(59779-930)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(59779-930) , pack(59779-930)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(59779-930)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(59779-930)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(59779-930)

Revised: 7/2022

Document Id: 91c8285c-570b-4cff-8f2d-f16dafd06189

Set id: 289ec101-c9a3-45f1-b2cd-8eaf8e580130

Version: 19

Effective Time: 20220711

CVS Pharmacy