Indications and uses
temporarily relieves cough due to minor throat and bronchial irritation loosens phlegm (mucus) helps rid bronchial passages of phlegm (mucus)
Safetussin
- Manufacturer
- Kramer Laboratories
- Effective date
- 2024-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:43:52
Label at a glance#
ProductSafetussin DM
Active ingredientDextromethorphan Hydrobromide, GUAIFENESIN
Label structure11 sections
Dosage and administration
do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 teaspoons every 4 hours children under 12 years do not use
Storage and handling
Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F) Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg Save this package for complete information
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
| Active ingredients (in each 5mL teaspoon) | Purpose |
| Dextromethorphan HBr, USP 10mg | Cough Suppressant |
| Guaifenesin, USP 100mg | Expectorant |
Uses
- temporarily relieves cough due to minor throat and bronchial irritation
- loosens phlegm (mucus)
- helps rid bronchial passages of phlegm (mucus)
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
- 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 if cough 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 - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
| age | dose |
| adults and children 12 years and over | 2 teaspoons every 4 hours |
| children under 12 years | do not use |
Other information
- Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F)
- Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg
Save this package for complete information
INACTIVE INGREDIENT SECTION
Inactive ingredients aspartame, benzoic acid, citric acid, glycerin, menthol, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water.
PRINCIPAL DISPLAY PANEL
SAFE FOR ADULTS WITH
HIGH BLOOD PRESSURE & DIABETES
Safetussin® DM
NON-DROWSY
Cough + Chest Congestion
Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Safe for adults with
● High Blood Pressure
● Diabetes
✓ Controls cough
✓ Loosens mucus
✓ Relieves chest congestion
SUGAR & ALCOHOL FREE
8.0 FL OZ (237mL)
SEGURO PARA ADULTOS CON
PRESIÓN ALTA Y DIABETES
Safetussin®
DM
NO SOMNOLIENTO
Tos + Congestión en el Pecho
Dextromethorphan HBr / Antitusivo
Guaifenesin / Expectorante
Seguro para adultos con
● Presión Alta
● Diabetes
✓ Controla la tos
✓ Afloja la muscosidad
✓ Alivia la congestion en el pecho
SIN AZÚCAR Y SIN ALCOHOL
8.0 FL OZ (237mL)
SAFE FOR ADULTS WITH
HIGH BLOOD PRESSURE & DIABETES
Safetussin® DM
Safetussin® contains:
✓ No decongestants
✓ No acetaminophen
✓ No sugar
✓ No alcohol
✓ No sorbitol
✓ No fructose
✓ No gluten
✓ No dyes
Pharmacist Recommended
Always read and follow label directions. Ask a doctor if you have individual health questions.
Questions? Comments?
Call 1-800-824-4894
©2020 Kramer Laboratories, Inc.
Bridgewater, NJ 08807
K0220
Safetussin® DM
NON-DROWSY
Cough + Chest Congestion
Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Safe for adults with
● High Blood Pressure ● Diabetes
✓ Controls cough
✓ Loosens mucus
✓ Relieves chest congestion
8.0 FL OZ (237mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED
SAFETY SEAL ON BOTTLE IS BROKEN OR MISSING.
K0220
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| Aspartame | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MINT | INACTIVE INGREDIENT | FV98Z8GITP | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Safetussin DM
- Dextromethorphan Guaifenesin
- Dextromethorphan Hydrobromide
- Dextromethorphan
- GUAIFENESIN
- Aspartame
- BENZOIC ACID
- CITRIC ACID MONOHYDRATE
- glycerin
- methylparaben
- MINT
- propylene glycol
- propylparaben
- Water
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55505-189 | 55505-189-36 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| Aspartame | Z0H242BBR1 | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| glycerin | PDC6A3C0OX | IACT |
| methylparaben | A2I8C7HI9T | IACT |
| MINT | FV98Z8GITP | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| propylparaben | Z8IX2SC1OH | IACT |
| Water | 059QF0KO0R | IACT |
| MENTHOL | L7T10EIP3A | IACT |
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | ELIXIR / ORAL | 100 mg/5ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CONCENTRATE / ORAL | 5.3 mg/1ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SOFT TISSUE | 0.02 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| Aspartame | ASPARTAME | Z0H242BBR1 | LOZENGE / ORAL | 136 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 608 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRALESIONAL | ADJ PH | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION/ DROPS / ORAL | 19 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | LIQUID / ORAL | 2 mg/1ml | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| Aspartame | ASPARTAME | Z0H242BBR1 | TABLET / ORAL | 87 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION, CONCENTRATE / ORAL | 0.5 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | LOTION / TOPICAL | 0.2 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | GEL / TOPICAL | 4 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CONCENTRATE / ORAL | 12.5 mg/5ml | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| Aspartame | ASPARTAME | Z0H242BBR1 | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v |
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 |
|---|---|---|---|---|---|---|
| 4aa1532a-3e92-4706-9d7b-f3f54dfbe426 | 93512e2b-6072-49d2-849e-0a0af0ec9d44 | 2025-12-23 | Warnings | 93512e2b-6072-49d2-849e-0a0af0ec9d44 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.