GenCare Headache Relief ACETAMINOPHEN ASPIRIN CAFFEINE PIONEER LIFE SCIENCES, LLC FDA Approved Uses: temporarily relieves minor aches and pains due to: •headache •a cold •arthritis •muscular aches •toothache •premenstrual & menstrual cramps
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Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
Inactive Ingredients
INACTIVE INGREDIENTS Microcrystalline cellulose Pregelatinized starch Stearic acid Colloidal silicon dioxide Magnesium stearate croscarmellose sodium PVK-K30 Sodium starch glycolate Hydroxy propyl methyl cellulose Polyethylene glycol Talc Titanium dioxide.
Strengths
250 mg 65 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache A Cold Arthritis Muscular Aches Toothache Premenstrual Menstrual Cramps
Pill Appearance
Shape: capsule Color: white Imprint: HH6

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D R16CO5Y76E 3G6A5W338E
Packaging

PL0219-00 GC Headache Relief ES 300ct

Package Descriptions
  • PL0219-00 GC Headache Relief ES 300ct

Overview

Uses: temporarily relieves minor aches and pains due to: •headache •a cold •arthritis •muscular aches •toothache •premenstrual & menstrual cramps

Indications & Usage

Uses: temporarily relieves minor aches and pains due to: •headache •a cold •arthritis •muscular aches •toothache •premenstrual & menstrual cramps

Dosage & Administration

DIRECTIONS ■ do not use more than directed ■ drink a full glass of water with each dose ■ adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours ■ children under 12 years: ask a doctor

Warnings & Precautions
Warnings: Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: •hives •facial swelling •asthma (wheezing) •shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 8 caplets in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you •are age 60 or older •have had stomach ulcers or bleeding problems •take a blood thinning (anticoagulant) or steroid drug •take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) •have 3 or more alcoholic drinks every day while using this product •take more or for a longer time than directed Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 beat. Do not use •if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Purpose

Purpose Acetaminophen 250 mg............................................................Pain reliever Aspirin 250 mg (NSAID*)..........................................................Pain reliever Caffeine 65 mg ..................................................................Pain reliever aid (*nonsteroidal anti-inflammatory drug)

Stop Use & Ask a Doctor

Stop use and ask doctor if ■an allergic reaction occurs. Seek medical help right away. ■you experience any of the following signs of stomach bleeding: ■feel faint ■vomit blood ■have bloody or black stools ■have stomach pain that does not get better ■ringing in the ears or loss of hearing occurs ■painful area is red or swollen ■pain gets worse for more than 10 days ■fever gets worse or lasts more than 3 days ■any new symptoms occur. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

QUESTIONS OR COMMENTS? Call +1-(732)-994-2808 or email [email protected]


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