FDA Label for Delsym Cough Plus Soothing Action
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- SORE THROAT WARNING
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR OR DENTIST IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 16 LOZENGE CARTON
Delsym Cough Plus Soothing Action Product Label
The following document was submitted to the FDA by the labeler of this product Reckitt Benckiser Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
Otc - Purpose
| Active ingredients (in each lozenge) | Purposes |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Menthol 5 mg | Oral pain reliever |
Uses
temporarily relieves
- sore throat
- sore mouth
- minor mouth irritation
- cough due to minor throat and bronchial irritation as may occur with the common cold
Sore Throat Warning
- If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Otc - Do Not Use
Do not use in a child under 6 years of age.
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
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor Or Dentist If
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling develops
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
- children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
- children under 6 years of age: do not use
Other Information
- tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
- store between 20-25°C (68-77°F)
Inactive Ingredients
D&C Yellow #10, FD&C Yellow #6, flavors, liquid glucose, propylene glycol, sucralose, sucrose, water
Questions?
Call 1-888-963-3382
You may also report side effects to this phone number.
Principal Display Panel - 16 Lozenge Carton
NDC 63824-164-16
Delsym®
COUGH +™
SOOTHING
ACTION
LOZENGES
Dextromethorphan HBr 5 mg (Cough Suppressant)
Menthol 5 mg (Oral Pain Reliever)
✓ Quiets Cough✓ Relieves Sore Throat✓ Soothing Action
16 LOZENGES
Honey
Lemon
* Please review the disclaimer below.