Broncochem Kids Cold and Flu

Broncochem Kids Cold and Flu
SPL v1
SPL
SPL Set ID b6559fb9-2dea-49c0-a274-3e77741a0ffd
Route
ORAL
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Propylene Glycol Glycerin Sorbitol Sucralose Citric Acid Monohydrate Disodium Hedta Povidone K90 Sodium Citrate Sodium Chloride Honey Propyl Gallate Fd&c Red No. 40 Aloe Vera Leaf Methylparaben Propylparaben Raspberry Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-21

Description

Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take: More than 4 doses in 24 hour, wich is the maximum daily amount for this product. With other drugs containing acetaminophen. Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly. allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include: Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.


Medication Information

Description

Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take: More than 4 doses in 24 hour, wich is the maximum daily amount for this product. With other drugs containing acetaminophen. Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly. allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include: Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.

Uses

Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.

Purose

Acetaminophen...........Analgesic

Guaifenesin................Expectorant

Phenylephrine.............Decongestant

Warnings

Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:

More than 4 doses in 24 hour, wich is the maximum daily amount for this product.

With other drugs containing acetaminophen.

Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.

allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:

Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.

Directions

Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 6 doses in a 24 hour period

Children from 6 to 12 years-----10mL or cc every 4 hours

Children under 6 years, ask your doctor

Quiestions?

1-561-338-5221 or visit us at www.broncochem.com

Overdose Warning

In case of accidental overdose. seek professional assistance or contact a poison control center inmediately

Other Information

store at 66-77*F (20-25*C), do not use if securety cap is altered or broken

Active Ingredients

Acetaminophen...................325.00mg

Guaifenesin........................200.00mg

Phenylephrine HCl..................10.00mg

Inactive Ingredients

Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water.

Stop Use and Ask A Doctor If

Symtoms last more than 5 days

Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions

If your child is taking the bloood thinning drug warfarin

Package Principal Display Panel

Keep Out of the Reach of Children

Keep out of the reach of children

Package Label Principal Display Panel

Ask A Doctor Before Use If Your Kid Have

Liver disease

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to acetaminophen or any other componet of this formula


Structured Label Content

Uses

Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.

Purose

Acetaminophen...........Analgesic

Guaifenesin................Expectorant

Phenylephrine.............Decongestant

Warnings

Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:

More than 4 doses in 24 hour, wich is the maximum daily amount for this product.

With other drugs containing acetaminophen.

Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.

allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:

Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.

Directions

Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 6 doses in a 24 hour period

Children from 6 to 12 years-----10mL or cc every 4 hours

Children under 6 years, ask your doctor

Quiestions?

1-561-338-5221 or visit us at www.broncochem.com

Overdose Warning (Overdose warning)

In case of accidental overdose. seek professional assistance or contact a poison control center inmediately

Other Information (Other information)

store at 66-77*F (20-25*C), do not use if securety cap is altered or broken

Active Ingredients

Acetaminophen...................325.00mg

Guaifenesin........................200.00mg

Phenylephrine HCl..................10.00mg

Inactive Ingredients (Inactive ingredients)

Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Symtoms last more than 5 days

Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions

If your child is taking the bloood thinning drug warfarin

Package Principal Display Panel (Package principal display panel)

Keep Out of the Reach of Children (Keep out of the reach of children)

Keep out of the reach of children

Package Label Principal Display Panel

Ask A Doctor Before Use If Your Kid Have (Ask a doctor before use if your kid have)

Liver disease

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to acetaminophen or any other componet of this formula


Advanced Ingredient Data


Raw Label Data

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