Indications and uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep
Cough Relief Grape
- Manufacturer
- P & L Development, LLC
- Effective date
- 2019-09-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:13:28
Label at a glance#
ProductCough Relief Grape
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections
Dosage and administration
take recommended dosage or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product shake well before using mL = milliliter age dose adults and children 12 years and over 10 mL every 6-8 hours not to exceed 4 doses in 24 hours children 6 to 11 years of age 5 mL every 6-8 hours not to exceed 4 doses in 24 hours children under 6 years of ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 5 mL)
Dextromethorphan HBr 15 mg
Purpose
Cough suppressant
Uses
- temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the impulse to cough to help you get to sleep
Warnings
Do not use
- if 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
- chronic cough that lasts such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
When using this product
do not use more than directed.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- take recommended dosage or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- shake well before using
- mL = milliliter
| age | dose |
| adults and children 12 years and over | 10 mL every 6-8 hours not to exceed 4 doses in 24 hours |
| children 6 to 11 years of age | 5 mL every 6-8 hours not to exceed 4 doses in 24 hours |
| children under 6 years of age | do not use |
Other information
- each 5 mL contains: sodium 2 mg
- store at 20-25º (68-77ºF). Do not refrigerate.
Inactive ingredients
anhydrous citric acid, D&C red #33, disodium EDTA, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum
Principal Display Panel
Children's Cough Relief
Dextromethorphan HBr 15 mg
Cough Suppressant
Relieves:
- cough
- minor throat & bronchial irritation
- impulse to cough
For ages 6 years and over
ALCOHOL-FREE
6-8 hour relief
Grape Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St.
Lynwood, CA 90262
Package Label
Products#
Every source-derived product name is available through these pages.
- Cough Relief Grape
- Dextromethorphan HBr
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- FD&C BLUE NO. 1
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- D&C RED NO. 33
- SODIUM BENZOATE
- SUCRALOSE
- SUCROSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49580-0454 | 49580-0454-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 12ecdcdc-e760-4155-9f25-a5484c21483e | 5ab03c64-7217-4293-91c5-4d453ff9b05d | 2019-09-04 | Warnings | 12ecdcdc-e760-4155-9f25-a5484c21483e 5ab03c64-7217-4293-91c5-4d453ff9b05d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.