Rycontuss Liquid Cherry Flavor

Rycontuss Liquid Cherry Flavor
SPL v5
SPL
SPL Set ID c91798fa-48ab-47a0-92da-4d44c2aafde0
Route
ORAL
Published
Effective Date 2018-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Red No. 33 Fd&c Red No. 40 Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-05-31

Description

Active ingredients                                                                                       Purpose Chlorpheniramine Maleate 2mg............................................................Antihistamine Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings  Do not use  - To sedate a child or to make a child sleepy.  - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psyquiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. - If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Indications and Usage

In case of overdose, get medical help or contact a poison control center right away.

Dosage and Administration


Adults and children 12 or older

2 tsp (10 mL) every 4 hours

Chidren age 6 - 12

1 tsp (5 mL) every 4 hours

Children younger than 6

Ask a doctor



Description

Manufactured for:  Okendpharma Inc,  4287 Constancia Ave. Villa Del Carmen Ponce, PR 00716  United States  Product of Puerto Rico

Section 44425-7

Other information  - Store at controlled room temperature between 15-30 C (58-86F)  - Avoid excessive heat or humidity.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if  - You get nervous, dizzy, or sleepless.  - Cough lasts more than 7 days, come back, or is accompanied by a fever, rash, or persistent headaches. These could be signs of a serious condition.  If pregnant or breast feeding ask a health professional before use.

Section 50567-7

When using this product  - Do not use more than directed.  - May cause marked drowsiness.  - Avoid alcoholic beverages.  - Alcohol, sedatives and tranquilizers may cause increased drowsiness.  - Be careful when driving a motor vehicle or operating machinery.  - Excitability may occur, especially with children.

Section 50568-5

Ask a doctor or pharmacist if you are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have  - Heart disease.  - Thyroid disease.  - Trouble urinating due to enlarged prostate gland.  - Glaucoma.  - Cough that occurs with too much phlegm (mucus).  - Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Section 51727-6

Inactive Ingredients

Citric acid, DandC red #33, FDandC red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucrose.

Section 51945-4

NDC  RYCONTUSS Liquid  CHERRY FLAVOR  ANTITUSSIVE NASAL  DECONGESTANT AND ANTIHISTAMINE  16 fl oz (1 print) (473 ml)  Lot #  Exp.Date

Section 53413-1

Questions or comments  Phone: 1-787-548-0016, Labor hours 8:00 am to 5:00 pm

Section 55105-1

Uses  - For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever  - Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold  - Temporarily restores freer breathing through the nose

Section 55106-9

Active ingredients                                                                                       Purpose

Chlorpheniramine Maleate 2mg............................................................Antihistamine

Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant

Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant


Structured Label Content

Indications and Usage (34067-9)

In case of overdose, get medical help or contact a poison control center right away.

Dosage and Administration (34068-7)


Adults and children 12 or older

2 tsp (10 mL) every 4 hours

Chidren age 6 - 12

1 tsp (5 mL) every 4 hours

Children younger than 6

Ask a doctor



Warnings and Precautions (34071-1)

Warnings  Do not use  - To sedate a child or to make a child sleepy.  - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psyquiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. - If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Description (34089-3)

Manufactured for:  Okendpharma Inc,  4287 Constancia Ave. Villa Del Carmen Ponce, PR 00716  United States  Product of Puerto Rico

Section 44425-7 (44425-7)

Other information  - Store at controlled room temperature between 15-30 C (58-86F)  - Avoid excessive heat or humidity.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if  - You get nervous, dizzy, or sleepless.  - Cough lasts more than 7 days, come back, or is accompanied by a fever, rash, or persistent headaches. These could be signs of a serious condition.  If pregnant or breast feeding ask a health professional before use.

Section 50567-7 (50567-7)

When using this product  - Do not use more than directed.  - May cause marked drowsiness.  - Avoid alcoholic beverages.  - Alcohol, sedatives and tranquilizers may cause increased drowsiness.  - Be careful when driving a motor vehicle or operating machinery.  - Excitability may occur, especially with children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have  - Heart disease.  - Thyroid disease.  - Trouble urinating due to enlarged prostate gland.  - Glaucoma.  - Cough that occurs with too much phlegm (mucus).  - Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Section 51727-6 (51727-6)

Inactive Ingredients

Citric acid, DandC red #33, FDandC red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucrose.

Section 51945-4 (51945-4)

NDC  RYCONTUSS Liquid  CHERRY FLAVOR  ANTITUSSIVE NASAL  DECONGESTANT AND ANTIHISTAMINE  16 fl oz (1 print) (473 ml)  Lot #  Exp.Date

Section 53413-1 (53413-1)

Questions or comments  Phone: 1-787-548-0016, Labor hours 8:00 am to 5:00 pm

Section 55105-1 (55105-1)

Uses  - For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever  - Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold  - Temporarily restores freer breathing through the nose

Section 55106-9 (55106-9)

Active ingredients                                                                                       Purpose

Chlorpheniramine Maleate 2mg............................................................Antihistamine

Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant

Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant


Advanced Ingredient Data


Raw Label Data

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