GOOD NEIGHBOR PHARMACY FLU AND SEVERE COLD DAYTIME- acetaminophen, phenylephrine hydrochloride powder, for suspension 
Amerisource Bergen

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Amerisource Bergen Flu and Severe Cold Daytime Drug Facts

Active ingredient (in each packet)

Acetaminophen 650 mg

Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms due to a cold or flu:
headache
minor aches and pains
sore throat
nasal and sinus congestion
temporarily reduces fever

Warnings

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

more than 6 packets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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

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.

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy or sleepless
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

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

do not use more than directed – see Liver warning
take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor

adults and children 12 years of age and over

dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

children 4 to under 12 years of age

consult a doctor

children under 4 years of age

do not use

if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

each packet contains: sodium 42 mg
store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, citric acid, colloidal silicon dioxide, D&C yellow no. 10, FD&C yellow no. 6, flavors, lecithin, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredients in Theraflu® Daytime Severe Cold

See New Warnings Information

Flu & Severe Cold

Daytime

Pain Reliever-Fever Reducer (Acetaminophen)

Nasal Decongestant (Phenylephrine HCl)

Nasal Congestion

Sore Throat

Headache

Body Ache

Fever

Natural Lemon Flavor

Flu and Severe Cold Daytime Carton Image #1

Flu and Severe Cold Daytime Carton Image #1

Flu and Severe Cold Daytime Carton Image #2

Flu and Severe Cold Daytime Carton Image #1

Flu and Severe Cold Daytime Carton Image #2

GOOD NEIGHBOR PHARMACY FLU AND SEVERE COLD  DAYTIME
acetaminophen, phenylephrine hydrochloride powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-988
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 16000 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 16000 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-988-136 in 1 CARTON08/21/200702/15/2013
116000 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/200702/15/2013
Labeler - Amerisource Bergen (007914906)

Revised: 11/2017
 
Amerisource Bergen