FLU AND SEVERE COLD AND COUGH NIGHTTIME - acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride powder, for solution 
CVS Pharmacy

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CVS Pharmacy, Inc. Flu and Severe Cold and Cough Drug Facts

Active ingredient (in each packet)

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

Warnings

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

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Theraflu® Severe Cold & Cough

See new warnings information

Flu & Severe Cold & Cough

Nighttime

Acetaminophen - Pain Reliever/Fever Reducer

Diphenhydramine HCl - Antihistamine/Cough Suppressant

Phenylephrine HCl - Nasal Decongestant

Nasal Congestion

Cough

Runny Nose

Sore Throat Pain

Sneezing

Body Ache

Headache/Fever

Honey Lemon Infused with Chamomile & White Tea Flavors

Flu and Severe Cold and Cough Carton

Flu and Severe Cold and Cough Carton


FLU AND SEVERE COLD AND COUGH  NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride   powder, for solution
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)59779-964
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
ASPARTAME 
SILICON DIOXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTODEXTRIN 
SODIUM CITRATE 
SUCROSE 
TRIBASIC CALCIUM PHOSPHATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
159779-964-916 POUCH In 1 CARTONNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/02/2010

Labeler - CVS Pharmacy (062312574)
Revised: 12/2010CVS Pharmacy