DailyMed - MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet, film coated

NDC Code(s): 11822-3900-1, 11822-3900-8
Packager: Rite Aid Corporation

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated June 14, 2024

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Active ingredients (in each caplet)
Acetaminophen 500 mg - Caffeine 60 mg - Pyrilamine maleate 15 mg

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
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Purpose
Pain reliever - Diuretic - Antihistamine

Pain reliever
Diuretic
Antihistamine
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Uses
for the temporary relief of these symptoms associated with menstrual periods: bloating - headache - water-weight gain - cramps - backache - fatigue - muscle aches
for the temporary relief of these symptoms associated with menstrual periods:
- bloating
- headache
- water-weight gain
- cramps
- backache
- fatigue
- muscle aches
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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 ...
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
- 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
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- use caution when driving a motor vehicle or operating machinery
- 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 heart rate. 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
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 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.

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Directions
do not take more than directed - 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 ...
- do not take more than directed
- 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
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Other information
see end flap for expiration date and lot number - store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium ...

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin
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Questions or comments?
1-800-426-9391

1-800-426-9391
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Principal Display Panel
NDC 11822-3900-8 - Compare to active ingredients in Midol® Complete* MENSTRUAL COMPLETE - ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE - pain reliever • diuretic • antihistamine - MULTI-SYMPTOM ...

NDC 11822-3900-8

Compare to active ingredients in Midol® Complete*

MENSTRUAL COMPLETE
ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
pain reliever • diuretic • antihistamine

MULTI-SYMPTOM RELIEF
of cramps, bloating, fatigue,
headache & backache

ACTUAL SIZE

24
CAPLETS

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

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

50844 ORG062339008

DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319 www.riteaid.com

SATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.

Rite Aid 44-390

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INGREDIENTS AND APPEARANCE

Product Information

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-3900
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, UNSPECIFIED (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:11822-3900-8	3 in 1 BOX	06/13/2024
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11822-3900-1	1 in 1 CARTON	06/19/2024
2		40 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 Drug	M013	06/13/2024

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(11822-3900)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(11822-3900) , pack(11822-3900)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(11822-3900)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(11822-3900)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(11822-3900)

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Published Date (What is this?)	Version	Files
Jun 21, 2024	3 (current)	download
Jun 17, 2024	2	download

	RxCUI	RxNorm NAME	RxTTY
1	1597298	acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet	PSN
2	1597298	acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet	SCD
3	1597298	APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral Tablet	SY

Label: MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet, film coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	11822-3900-1
2	11822-3900-8

Label: MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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

Number of versions: 2

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

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

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

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.