Kgs
FDA Label NDC 63922-605

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kingsway for the product Kgs (NDC 63922-605). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Capsule)

Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg

Purpose

Pain reliever

Antihistamine

Uses

■temporarily relieves these symptoms of hay fever and other upper respiratory allergies: 

■runny nose and sneezing ■itchy, watery eyes

■temporarily relieves these additional symptoms of hay fever or other respiratory allergies:

■headache ■minor aches and pains

Warnings

Liver warningThis product contains acetaminophen. The maximum daily dose of this product is 12 capsules in 24 hours. Severe liver damage many occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.

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 reactionto this product or any of its ingredients

■to make a child sleepy

Ask A Doctor Before Use If You Have

■ liver disease ■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis ■ Glaucoma

Ask A Doctor Or Pharmacist If You Are

■ taking the blood thinner drug, warfarin

■ taking sedatives or tranquilizers

When Using This Product

■ do not exceed recommended dosage

■ drowsiness may occur ■alcohol, sedatives and tranquilizers may increase drowsiness

■ avoid alcoholic drinks ■be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop Use And Ask A Doctor If

■ nervousness, dizziness, or sleepleessness occur ■ pain gets worse or lasts more than 7 days

■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur

This could be signs of a serious condition

If Pregnant Or Breast-Feeding

ask a health professional before

Keep Out Of Reach Of Children

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

Directions

■ do not take more than directed (see Liver warning)

adults and children 12 years of age and over

■ take 2 caplets every 4 hours. ■swallow whole-do not crush, chew dissolve 

■ do not take more than 12 capsules in 24 hours. ■ children under 12 years ask a doctor

Inactive Ingredients

Caffeine, Carmine, Corn Starch, FDC Yellow 5, FDC Blue 1,hydroxy methylcellulose, Sugar

Package Label

Image Description (Alrgncaplbl)

Image Description (Alrgncaplbl)

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