OTC Medication Information: Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg

ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG- caffeine, pyrilamine maleate and acetaminophen 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.

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

  • Do not take more than the recommended dose
  • Adults and children 12 years and over: 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

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)

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ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG
acetaminophen 500mg caffeine 60mg pyrilamine maleate 15mg tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2310
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (CAFFEINE) CAFFEINE 60 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
HYPROMELLOSES
D&C RED NO. 33
GLYCERIN
FERROSOFERRIC OXIDE
LIGHT MINERAL OIL
POVIDONE
HYDROXYETHYL CELLULOSE, UNSPECIFIED
FD&C BLUE NO. 1
GELATIN
STARCH, CORN
SHELLAC
SORBITOL
TALC
TRIACETIN
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
TITANIUM DIOXIDE
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
Product Characteristics
Color blue (DARK BLUE and LIGHT BLUE) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code S79
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-2310-24 24 TABLET in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/05/2019
Labeler — WALGREENS CO. (008965063)

Revised: 10/2020 WALGREENS CO.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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