Indications and uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Histiacil NF Children
- Manufacturer
- OPMX LLC
- Effective date
- 2026-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- daily-update
- Hydrated at
- 2026-10-13 04:03:15
Label at a glance#
ProductDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections
Dosage and administration
take evey 4 hours do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product Age Dose Adults and children 12 years and over 2 teaspoonful (10 mL) Children 6 to under 12 years 1 teaspoonful (5 mL) Children under 6 years Ask a doctor
Storage and handling
Store at 20°-25°C (68° -77°F). Do not refrigerate. Retain carton for future reference on full labeling
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each 5 mL) Purpose
Dextromethorphan HBr USP 10 mg............. Cough suppressant
Guaifenesin, USP 100 mg............................... Expectorant
OTC - PURPOSE SECTION
Relieves:
• Chest congestion / Mucus
• Cough
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
OTC - DO NOT USE SECTION
- Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
OTC - STOP USE SECTION
Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If pregnant or breast-feedingask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take evey 4 hours
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
Age | Dose |
Adults and children 12 years and over | 2 teaspoonful (10 mL) |
Children 6 to under 12 years | 1 teaspoonful (5 mL) |
Children under 6 years | Ask a doctor |
Other information
- Store at 20°-25°C (68° -77°F).
- Do not refrigerate.
- Retain carton for future reference on full labeling
Inactive ingredients
citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.
SPL UNCLASSIFIED SECTION
Questions or comments?
Call 619-600-5632
Tamper evident: Do not use if inner seal under cap is broken or missing.
Exclusively distributed by
OPMX
Chula Vista, CA91910
Phone: 619-600-5632
Manufactured in
FDA Registered Facility
In the USA
PRINCIPAL DISPLAY PANEL PENTREXCILINA CHILDREN
PRINCIPAL DISPLAY PANEL BROSOLVAN
PRINCIPAL DISPLAY PANEL HISTIACIL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  opmx.us/ | -Pentrexcilina Children NF EN-ES (RTE) Rev 11.2024 (AKRON)_001.jpg, -Brosolvan Children 4 fl oz (RTE) EN-ES Rev 11.2024 (AKRON)_001.jpg, -Histiacil Children EN-ES (RTE) Rev 11.2024 (AKRON)_001.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- ANHYDROUS CITRIC ACID
- GLYCERIN
- MENTHOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SACCHARIN SODIUM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69729-035 | 69729-035-04 |
| 69729-036 | 69729-036-04 |
| 69729-069 | 69729-069-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-05-15 | full-release | 2026-06-01 01:01:05 |
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 |
|---|---|---|---|---|---|---|
| 352f8de3-8fcf-4098-e063-6294a90ace4d | 8bb85b23-e9f6-48c7-84b0-15e0e26df4c5 | 2025-05-15 | Warnings | 8bb85b23-e9f6-48c7-84b0-15e0e26df4c5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.