Indications and uses
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation
do not take more then 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use
store between 20-25°C (68-77°F). Do not refrigerate.
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
Cough suppressant
Expectorant
Nasal decongestant
taking any other oral nasal decongestant or stimulant.
do not use more than directed.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to active ingredients in Robitussin® Peak Cold Multi-Symptom Cold CF*
Adult
Tussin CF
Multi-Symptom Cold
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Relieves:
Non-drowsy
for ages 12 years and over
Alcohol free
Dosing Cup Included
FL OZ (mL)
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49580-0382-4 | 2023-06-07 | C162847 | 48780-1 | f386c64a-1ecb-0266-e053-dadaa90a7c1a | Drug Facts |
| 49580-0382-4 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1ecb-0266-e053-dadaa90a7c1a | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 2 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | 2 | |
| MENTHOL, UNSPECIFIED FORM | INACTIVE INGREDIENT | L7T10EIP3A | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49580-0382 | 49580-0382-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LOTION / TOPICAL | 211 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / ORAL | 197 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 48 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | OIL / TOPICAL | 2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| MENTHOL, UNSPECIFIED FORM | MENTHOL | L7T10EIP3A | INHALANT / NASAL | 32 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE, DENTIFRICE / DENTAL | 0.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | ELIXIR / ORAL | 90 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | OINTMENT / TOPICAL | ADJ PH | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / SUBLINGUAL | 36 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LOZENGE / TRANSMUCOSAL | 44 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAMUSCULAR | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | CREAM / TOPICAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE, LIQUID FILLED / ORAL | 360 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | INJECTION / SUBCUTANEOUS | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg |
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 |
|---|---|---|---|---|---|---|
| 46820c73-44d1-4a32-a367-0d1dda349a52 | 889fddba-cc5e-47de-9e4d-8ab61a7b44a7 | 2023-06-07 | Warnings | 46820c73-44d1-4a32-a367-0d1dda349a52 889fddba-cc5e-47de-9e4d-8ab61a7b44a7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.