824d452d-3075-4d94-bfde-704b2d969c8c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
Uses
- temporarily relieves
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50569-3
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
Section 50570-1
Do not use in a child under 4 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Section 53413-1
877-434-2036
Section 55105-1
|
Active ingredients (in each 5 mL, 1 teaspoonful) |
Purposes |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough suppressant |
| Phenylephrine HCl, USP 1.25 mg | Nasal decongestant |
Directions
- May be given every 6 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.
| Children under 4 years of age | do not use |
| Children 4 to under 6 years of age | 1-1½ tsp. (5-7.5 mL) |
| Children 6 to under 12 years of age | 1½-3 tsp. (7.5-15 mL) |
Other Information
- each teaspoon contains: sodium 2 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Artificial Flavor, Benzoic Acid, Citric Acid, EDTA Disodium, FD&C Red #40, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
When Using This Product
- do not exceed recommended dosage
Stop Use and Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.
Principal Display Panel 118 Ml Bottle Carton
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
Daytime
Cough & Cold
ACCURATE DOSING
BY WEIGHT
Dextromethorphan HBr
(Cough Suppressant)
Phenylephrine HCl
(Nasal Decongestant)
Cough
Stuffy Nose
For Ages 4 to under 12
Compares to the active
ingredients in Children's
Triaminic® Day Time
Cold & Cough.
CHERRY
FLAVOR
4 FL.OZ.
(118 mL)
NDC 45014-152-04
Structured Label Content
Uses
- temporarily relieves
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50569-3 (50569-3)
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
Section 50570-1 (50570-1)
Do not use in a child under 4 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Section 53413-1 (53413-1)
877-434-2036
Section 55105-1 (55105-1)
|
Active ingredients (in each 5 mL, 1 teaspoonful) |
Purposes |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough suppressant |
| Phenylephrine HCl, USP 1.25 mg | Nasal decongestant |
Directions
- May be given every 6 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.
| Children under 4 years of age | do not use |
| Children 4 to under 6 years of age | 1-1½ tsp. (5-7.5 mL) |
| Children 6 to under 12 years of age | 1½-3 tsp. (7.5-15 mL) |
Other Information (Other information)
- each teaspoon contains: sodium 2 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)
Artificial Flavor, Benzoic Acid, Citric Acid, EDTA Disodium, FD&C Red #40, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
When Using This Product (When using this product)
- do not exceed recommended dosage
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
Daytime
Cough & Cold
ACCURATE DOSING
BY WEIGHT
Dextromethorphan HBr
(Cough Suppressant)
Phenylephrine HCl
(Nasal Decongestant)
Cough
Stuffy Nose
For Ages 4 to under 12
Compares to the active
ingredients in Children's
Triaminic® Day Time
Cold & Cough.
CHERRY
FLAVOR
4 FL.OZ.
(118 mL)
NDC 45014-152-04
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:55:20.505792 · Updated: 2026-03-14T22:52:50.897919