ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG- acetaminophen 500mg caffeine 60mg pyrilamine maleate 15mg tablet 
WALGREENS CO.

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.

----------

Walgreens Menstrual Complete Pain Relief
Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg

Acetaminophen 500mg

Caffeine 60mg

Pyrilamine maleate 15mg

ammonium hydroxide, croscarmellose sodium, D&C red No. 33 aluminum lake, ethyl cellulose, FD&C blue No. 1 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, light mineral oil, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch, propylene glycol, shellac glaze, sorbitol sorbitan, talc, titanium dioxide, triacetin

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

Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue.

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 contains acetaminophen, 3 or more alcoholic drinks every day while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions or severe allergic reactions. Symptoms may include: skin reddening, blisters, rash, hives, 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 for more than 10 days, fever gets worse or lasts for 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Pain reliever

Nighttime sleep-aid

Store at room temperature between 20-25 ºC (68-77 ºF)

231

ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG 
acetaminophen 500mg caffeine 60mg pyrilamine maleate 15mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2310
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POVIDONE (UNII: FZ989GH94E)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
TRIACETIN (UNII: XHX3C3X673)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
Colorblue (DARK BLUE and LIGHT BLUE) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code S79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-2310-2424 in 1 PACKAGE; Type 0: Not a Combination Product07/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/05/2019
Labeler - WALGREENS CO. (008965063)

Revised: 10/2020
Document Id: b1a7b290-79e0-6713-e053-2995a90a3ef9
Set id: 982faa74-d498-cd1e-e053-2995a90afa1e
Version: 2
Effective Time: 20201014
 
WALGREENS CO.