Indications and 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.
BRONCOCHEM
- Manufacturer
- LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Effective date
- 2017-04-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:49:44
Label at a glance#
ProductBRONCOCHEM KIDS COLD AND FLU
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure14 sections
Dosage and administration
Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 4 doses in a 24 hour period Children from 6 to 12 years-----10mL or cc every 6 hours Children form 2 to 6 years------5mL or cc every 6 hours Children under 2 years, ask your doctor
Contacts and useful links#
Websitewww.broncochem.com
www.broncochem.com
www.broncochem.comLabel contents#
Full prescribing information#
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.
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.
Active Ingredients
Acetaminophen...................325.00mg
Guaifenesin........................200.00mg
Phenylephrine HCl..................5.00mg
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
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
Keep out of the reach of children
Keep out of the reach of children
Overdose warning
In case of accidental overdose. seek professional assistance or contact a poison control center inmediately
Directions
Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 4 doses in a 24 hour period
Children from 6 to 12 years-----10mL or cc every 6 hours
Children form 2 to 6 years------5mL or cc every 6 hours
Children under 2 years, ask your doctor
Other information
store at 66-77*F (20-25*C), do not use if securety cap is altered or broken
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.
Quiestions?
1-561-338-5221 or visit us at www.broncochem.com
Purose
Acetaminophen...........Analgesic
Guaifenesin................Expectorant
Phenylephrine.............Decongestant
Package principal display panel
Package Label Principal Display Panel
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1116568 | acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 1 |
| 1116568 | acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1116568 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 1 |
| 1116568 | acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 1 |
| 1116568 | APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 1 |
| 1116568 | APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65131-054-18 | BRONCOCHEMKIDS COLD AND FLU | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | 1 | |
| 65131-054-18 | BRONCOCHEMKIDS COLD AND FLU | 1 in 1 BOX | SYRUP | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65131-054 | BRONCOCHEM KIDS COLD AND FLU (ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL] | 1 | Current NDC, Legacy NDC, 2 package rows | 20170501_523561fb-f6a7-4cde-9be2-bba02e60e208.zip |
Products#
Every source-derived product name is available through these pages.
- BRONCOCHEM KIDS COLD AND FLU
- ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- GUAIFENESIN
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65131-054 | 65131-054-18 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| DISODIUM HEDTA | KME849MC7A | IACT |
| POVIDONE K90 | RDH86HJV5Z | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| HONEY | Y9H1V576FH | IACT |
| PROPYL GALLATE | 8D4SNN7V92 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| RASPBERRY | 4N14V5R27W | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BRONCOCHEM KIDS COLD AND FLU | ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 523561fb-f6a7-4cde-9be2-bba02e60e208 | 2017-04-06 | Warnings | 65131-054-18 65131-054 65131005418 7ec85034-cc70-4465-bc25-9c700731eb02 523561fb-f6a7-4cde-9be2-bba02e60e208 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.