TUSSIN CF NIGHTTIME COUGH AND COLD- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

TUSSIN CF NIGHTTIME COUGH and COLD by

Drug Labeling and Warnings

TUSSIN CF NIGHTTIME COUGH and COLD by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Acetaminophen 640 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

• temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
  • sore throat
  • headache
  • minor aches and pains
  • runny nose
  • sneezing
  • itchy, watery eyes
  • cough
  • nasal congestion
  • itching of the nose or throat
• temporarily reduces fever

Warnings

liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert:  Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• to sedate a child or to make a child sleepy
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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 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.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
• taking any other oral nasal decongestant or stimulant
• taking any other pain reliever/fever reducer

When using this product,

• do not exceed recommended dose (see Overdose warning)
• excitability may occur, especially in children
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• nervousness, dizziness, or sleeplessness occur
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts

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.

Taking more than the recommended dose (overdose) may cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• keep dosing cup with product
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age
• adults and children 12 years and over: (20 mL) every 4 hours
• children under 12 years: do not use

Other information

• each 20 mL contains: sodium 14 mg
• store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, disodium EDTA, FD&C red #40, flavors, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Robitussin® Nighttime Multi-Symptom Cold CF*

Nighttime 

TUSSIN CF 

ACETAMINOPHEN Pain Reliever; Fever Reducer

DIPHENHYDRAMINE HCI Antihistamine Cough Suppressant

PHENYELEPHRINE HCI Nasal Decongestant

Adult Cough & Cold

Relieves:

• Cough
• Stuffy nose
• Runny nose
• Sore throat
• Aches
• Fever

Dosage cup provided

For ages 12 & over

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Robitussin® Nighttime Multi-Symptom Cold CF.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com  1-800-SHOP-CVS

Product of USA

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

 

CVS Nighttime Tussin CF

INGREDIENTS AND APPEARANCE

TUSSIN CF NIGHTTIME COUGH AND COLD 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-095
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	640 mg  in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-095-04	1 in 1 BOX	07/31/2014	12/31/2020
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/31/2014	12/31/2020

Labeler - CVS Pharmacy (062312574)