SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan, phenylephrine powder, for solution

Severe Cold and Cough Daytime by

Drug Labeling and Warnings

Severe Cold and Cough Daytime by is a Otc medication manufactured, distributed, or labeled by Chain Drug Manufacturing Assn. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SEVERE COLD AND COUGH DAYTIME 
acetaminophen, dextromethorphan, phenylephrine powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-290
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	BERRY (Infused with Menthol and Green Tea Flavors)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-290-06	6 in 1 CARTON	07/25/2018
1		1 in 1 PACKET; 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	07/25/2018

Labeler - Chain Drug Manufacturing Assn (011920774)