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 Type HUMAN OTC DRUG NDC Product Code (Source) 59779-964
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
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     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59779-964-91 6 POUCH In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/02/2010

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