Tussi Pres (Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide) Syrup [Kramer Novis] -

TUSSI PRES (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]
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NDC	52083-231-04, 52083-231-10, 52083-231-16
Set ID	0d4ee530-2a5c-41a0-88bf-ac92d538661b
Category	HUMAN OTC DRUG LABEL
Packager	Kramer Novis
Generic Name
Product Class	alpha-1 Adrenergic Agonist
Product Number
Application Number	PART341

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Drug Facts
Active Ingredients (in each 5mL tsp)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg
Purposes

Cough suppressant

Expectorant

Nasal decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves these symptoms occurring with cold:
  - nasal congestion
  - cough due to minor throat and bronchial irritation
Warnings
Do not use:
- in a child under 2 years of age
- if you are 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

• heart disease • high blood pressure
• thyroid disease • diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if
• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• 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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental 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


EVERY 4 HOURS	ADULTS AND CHILDREN 12 YEARS AND OVER	10 mL (2 tsp)
	CHILDREN 6 YEARS TO UNDER 12 YEARS	5 mL (1 tsp)
	CHILDREN 2 YEARS TO UNDER 6 YEARS	2.5 mL (1/2 tsp)
	CHILDREN UNDER 2 YEARS OF AGE	do not use

Other information
- Tamper evident feature. Do not use if inner seal is torn, broken or missing.
- Store at controlled room temperature 15-30°C (59-86°F).
- Avoid excessive heat and humidity.
Inactive ingredients

Citric acid, FD&C Red 40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.
SPL UNCLASSIFIED SECTION

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR, ALCOHOL, SACCHARIN & SORBITOL FREE

CHERRY FLAVOR

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917

Tel: (787) 767-2072 www.kramernovis.com
Packaging

INGREDIENTS AND APPEARANCE

TUSSI PRES
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52083-231
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red (CHERRY RED)	Score
Shape		Size
Flavor	CHERRY (SOUR CHERRY)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52083-231-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2011
2	NDC:52083-231-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2011	07/12/2017
3	NDC:52083-231-10	10 mL in 1 PACKET; Type 0: Not a Combination Product	03/28/2011