SANATOS DAY- acetaminophen, dextromethorphan hydrobromide, phenylephrine liquid

Sanatos by

Drug Labeling and Warnings

Sanatos by is a Otc medication manufactured, distributed, or labeled by Pharmalab Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                               Purpose

(in each 15 mL tablespoon)

Acetaminophen 325m........         Pain Reliever/Fever Reducer

Dextromethorphan HBr 10mg......    Cough Suppressant

Phenylephrine HCl 5mg..................Nasal Decongestant

PURPOSE

Uses: Temporarily relieves common cold/flu symptoms:

• Nasal Congestion
• Cough due to Minor Throat and Bronchial Irritation
• Sore Throat
• Headache
• Minor Aches and Pains
• Fever

WARNINGS

Warnings: Do not exceed recommended dosage.

Do not give to children under 12 years of age.

Liver Toxicity may occur if:

• Recommended dosage is exceeded
• Used with other products containing acetaminophen
• Used with moderate amounts of alcohol

Alcohol Warning: If you consume 3 or more alcoholic drinks, ask your doctor whether you should take acetaminophen or other pain relievers. Acetaminophen may cause liver damage.
Sore Throat Warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

DO NOT USE

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 two weeks after stopping the MAOI drug. If yuo do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

ASK DOCTOR

Ask a doctor before use if you have:

• Heart Disease
• Thyroid Disease
• Diabetes
• High Blood Pressure
• Trouble urinating due to enlarged prostate gland
• Cough that occurs with too much phlegm(mucus)
• Persistent or chronic cough as occurs with smoking, asthma or emphysema

WHEN USING

When using this product, do not use more than directed

STOP USE

Stop Use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms get worse or lasts more than 5 days(children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with rash or headache that lasts. This could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions:

• take only as recommended.

See Overdose warning.

• use dose cup or tablespoon(TBSP)
• do not use more than 5 doses(children) or 6 doses(adults) in 24 hours

Adults and children 12 years and older: Take 2 TBSP(30ml) every 4 hours, while symptoms persist or as directed by a doctor
Children 6 to under 12 years of age: take 1 TBSP 15ml every 4 hours, while symptoms persist or as directed by a doctor
Children under 6 years of age: Consult a doctor. Do not use this adult extra strength product in children under 6 years of age. This will provide more than the recommended dose(overdose) of acetaminophen and cause serious problems.

INDICATIONS & USAGE

Other information: each tablespoon contains sodium 50 mg

INACTIVE INGREDIENT

QUESTIONS

Questions? (302) 725-0692

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANATOS  DAY
acetaminophen, dextromethorphan hydrobromide, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14505-398
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	CHERRY (CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14505-398-06	177 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/04/2010

Labeler - Pharmalab Enterprises Inc (174401088)

Registrant - Pharmalab Enterprises Inc (174401088)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmalab Enterprises Inc		174401088	manufacture