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Generic: dexbrompheniramine maleate, acetaminophen is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Common Cold Rhinitis, Allergic, Perennial Sinusitis Urticaria

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Drug Facts


Active Ingredients (in Each Caplet)


Acetaminophen 650 mg

Dexbrompheniramine Maleate 2 mg

Purpose


Analgesic, Antipyretic (Fever Reducer)

Antihistamine

Uses:


temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps    • minor pain of arthritis • relieves runny nose, and sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies. Temporarily reduces fever.

Warnings


Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 caplets (3,900 mg) 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 • bulers • rash. If skin reaction occurs, stop use and seek medical help right away.

Do not use : with any other product containing acetaminophen (prescription or nonprescription), this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. When using this product do not exceed recommended dose.

Ask a doctor before use if you have: •liver disease • breathing problems such as emphysema or chronic bronchitis • glaucoma or difficulty in urination due to enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are taking: • the blood thinning drug warfarin • sedatives or tranquilizers

While using this product:• excitability may occur  • drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if: • pain gets worse or lasts for more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present. 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


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

Directions:

 Adults and children 12 years of age and older:
take 1 caplet every 4 - 6 hours or as directed by a doctor

Do not exceed 6 caplets in 24 hours
 Children under 12 years : Consult a doctor 

Other Information:


• Tamper Evident. Do not use if seal is broken.

• Store at controlled room temperature 15° to 30°C (59° to 86°F). • Avoid excessive heat and humidity.

Inactive Ingredients:


corn starch, hydroxypropylmethylcellulose, maltodextrin,  microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and stearic acid


Pain Reliever

Fever Reducer

Antihistamine

Sugar & Dye Free 

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072

www.kramernovis.com

Packaging




DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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