SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan, phenylephrine powder, for solution 
Chain Drug Manufacturing Assn

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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QC Quality Choice Severe Cold and Cough Daytime Berry infused with Menthol and Green Tea Flavors 6 Packets

Active ingredients (in each packet)

Acetaminophen 650 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Uses

temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
cough due to minor throat and bronchial irritation
temporarily reduces fever

Warnings

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

more than 4,000 mg of acetaminophen 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

in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
symptoms do not get better or worsen
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt 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
take every 4 hours; while symptoms persist. Do not to exceed 5 packets in 24 hours unless directed by a doctor

Age

Dose

Adults and children 12 years of age and over

One packet

Children under 12 years of age

Do not use

dissolve contents of one packet into 8 oz hot water; sip while hot. Consume entire drink within 10-15 minutes
If using a microwave, add contents of one packet 8 oz. of cool water: Stir briskly before and after heating: Do not overheat.

Other information

each packet contains: potassium 6mg
store at room temperature. Protect from excessive heat and moisture.

Inactive ingredients

citric acid, FD &C blue # 1, FD & C red # 40,flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose

Questions or Comments?

1-866-467-2748

Principal Display

QC Quality Choice

*Compare to the Active Ingredients in Theraflu® Daytime Severe Cold &Cough

SEVERE COLD & COUGH

Daytime

Acetaminophen

Pain Reliever/ Fever Reducer

Dextromethorphan HBr

Cough suppressant

Phenylephrine HCl

Nasal Decongestant

Aspartame Free ●Sodium Free

Relieves:

 
Nasal Congestion
 
Cough/Body Ache
 
Sore Throat Pain
 
Headache/Fever

Berry Infused with Menthol & Green Tea Flavors

6 Packets

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Daytime Severe Cough & Cold

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

Distributed by: C.D.M.A., Inc

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

QC Quality Choice Severe Cold and Cough Daytime Berry Infused with Menthol and Green Tea Flavors 6 Packets
SEVERE COLD AND COUGH DAYTIME 
acetaminophen, dextromethorphan, phenylephrine powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-290
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (Infused with Menthol and Green Tea Flavors) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-290-066 in 1 CARTON07/25/2018
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/25/2018
Labeler - Chain Drug Manufacturing Assn (011920774)

Revised: 1/2022
Document Id: 3c291770-4524-474a-ad3f-4fc34416f754
Set id: 26d2d39a-6d37-45d9-a4f9-4015cc97158b
Version: 3
Effective Time: 20220118
 
Chain Drug Manufacturing Assn