sanatos children cough & congestion cherry (apta)

sanatos children cough & congestion cherry (apta)
SPL v4
SPL
SPL Set ID 60437d86-9e13-8d8a-e053-2991aa0a2317
Route
oral
Published
Effective Date 2024-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (100 mg) dextromethorphan (5 mg)
Inactive Ingredients
anhydrous citric acid dextrose monohydrate d&c red no. 33 fd&c red no. 40 glycerin maltitol propylene glycol water saccharin sodium sodium benzoate sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2016-01-01

Description

Active Ingredients (in each teaspoonful, 5 mL) Purposes Dextromethorphan HBr 5 mg ..... Cough Suppressant Guaifenesin 100 mg ..... Expectorant


Medication Information

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Directions
  • do not give a child more than 6 doses in any 24-hour period
Age Dose
Children 6 to under 12 years of age 1-2 teaspoonfuls (tsps) every 4 hours
Children 2 to under 6 years of age ½-1 teaspoonful (tsp) every 4 hours
Children under 2 years of age consult a doctor
Other Information
  • per teaspoonful (5mL) contains: 3mg Sodium
  • store at 20- 25º C (68- 77º F)
  • do not refrigerate
  • dosage cup included

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Inactive Ingredients

Anhydrous citric acid, D&C red #33, dextrose monohydrate, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum.

Description

Active Ingredients (in each teaspoonful, 5 mL) Purposes Dextromethorphan HBr 5 mg ..... Cough Suppressant Guaifenesin 100 mg ..... Expectorant

Principal Display Panel

Questions?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Section 55105-1
Active Ingredients

(in each teaspoonful, 5 mL)
Purposes
Dextromethorphan HBr 5 mg ..... Cough Suppressant
Guaifenesin 100 mg ..... Expectorant
Do Not Use

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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Distributed By:

PHARMDEL LLC

New Castle, DE 19720

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away

Ask A Doctor Before Use, If the Child Has A
  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Stop Use and Ask A Doctor, If the Child Has A
  • cough that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a persistent headache. These could be signs of a serious condition.

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Directions
  • do not give a child more than 6 doses in any 24-hour period
Age Dose
Children 6 to under 12 years of age 1-2 teaspoonfuls (tsps) every 4 hours
Children 2 to under 6 years of age ½-1 teaspoonful (tsp) every 4 hours
Children under 2 years of age consult a doctor
Other Information (Other information)
  • per teaspoonful (5mL) contains: 3mg Sodium
  • store at 20- 25º C (68- 77º F)
  • do not refrigerate
  • dosage cup included

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, D&C red #33, dextrose monohydrate, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum.

Principal Display Panel

Questions?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Section 55105-1 (55105-1)
Active Ingredients

(in each teaspoonful, 5 mL)
Purposes
Dextromethorphan HBr 5 mg ..... Cough Suppressant
Guaifenesin 100 mg ..... Expectorant
Do Not Use (Do not use)

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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Distributed By: (Distributed by:)

PHARMDEL LLC

New Castle, DE 19720

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

In case of overdose, get medical help or contact a Poison Control Center right away

Ask A Doctor Before Use, If the Child Has A (Ask a doctor before use, if the child has a)
  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Stop Use and Ask A Doctor, If the Child Has A (Stop use and ask a doctor, if the child has a)
  • cough that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a persistent headache. These could be signs of a serious condition.

Advanced Ingredient Data


Raw Label Data

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