ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE- acetaminophen,caffeine and pyrilamine maleate tablet 
APNAR PHARMA LP

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.

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Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets

Caution: Do not use if imprinted seal under cap is broken or missing

Drug facts

Active Ingredient (in each tablet)


Acetaminophen USP....... 500 mg

Caffeine USP....................60 mg

Pyrilamine Maleate USP......15 mg

Purpose

Pain reliever/Diuretic/Antihistamine

Use(s)

for the temporary relief of these symptoms associated with menstrual periods:

Warnings:

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy Alert:

Acetaminophen may cause severe skin or severe allergy reactions. Symptoms may include:

If a skin or general allergic reaction occurs, stop use and seek medical help right away

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, ask a health care professional before use.

Overdose warning
In case of overdose, get medical help or contact a poison control center 1-800-222-1222 right away. Quick medical help attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

pregelatinized starch, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, talc

Questions or comments?

1-855-642-2594

Manufactured for:

Apnar Pharma LP

CHINO, CA, 91710

Rev.: 05/2022

†This product is not manufactured or distributed by Bayer Healthcare, LLC owner of the registered trademark Midol Complete®

APNAR PHARMA LP

NDC: 24689-121-01

Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets -20's Tablets

ACP tablet-20s tablets

APNAR PHARMA LP

NDC: 24689-121-02

Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets -500's Tablets

ACP tablets-500s

ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE 
acetaminophen,caffeine and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code LT16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-121-0120 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2022
2NDC:24689-121-02500 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/05/2022
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
Apnar Pharma Private Limited876730408analysis(24689-121) , manufacture(24689-121)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917pack(24689-121) , label(24689-121)

Revised: 1/2023
Document Id: f17e72c0-45e7-1e82-e053-2a95a90a115f
Set id: e2308622-0b91-3cb4-e053-2a95a90a6149
Version: 2
Effective Time: 20230105
 
APNAR PHARMA LP