SEVERE COLD AND FLU MAXIMUM STRENGTH, DAYTIME, NON-DROWSY- acetaminophen. dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Severe Cold and Flu by

Drug Labeling and Warnings

Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant 

Uses

• temporarily relieves common cold and flu symptoms:

• minor aches and pains
• sinus congestion and pressure
• sore throat
• fever
• headache
• nasal congestion
• cough due to minor throat and bronchial irritation 

• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make 
  coughs more productive

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:

• blisters
• rash
• skin reddening  

 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

• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• liver disease
• thyroid disease
• diabetes
• heart disease
• high blood pressure
• difficulty in urination due to enlargement of the prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 occur
• pain, nasal congestion, or cough 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
• cough comes back or occurs with rash or headache that lasts.
  

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 take more than directed
• do not take more than 8 caplets in 24 hours
• adults and children 12 years and over: take 2 caplets every 4 hours
• children under 12 years: ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

LEADER™

NDC: 70000-0289-1

Maximum Strength ι Daytime ι Non-Drowsy

Severe Cold & Flu

Acetaminophen ι Pain Reliever / Fever Reducer
Dextromethorphan HBr ι Cough Suppressant
Guaifenesin ι Expectorant
Phenylephrine HCl ι Nasal Decongestant

Relief of:
Headache, Fever, Sore Throat,
Minor Aches & Pains,
Nasal/Sinus Congestion & Sinus Pressure,
Cough, Chest Congestion

12 CAPLETS

ACTUAL SIZE

COMPARE TO VICKS® DAYQUIL®
SEVERE COLD & FLU MAX STRENGTH
active ingredients*

100% Money
Back Guarantee

*This product is not manufactured or distributed by Procter & Gamble.
owner of the registered trademark Vicks® DayQuil® Severe Cold & Flu
Max Strength.

50844     REV0417A64002

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERING

CIN 5326152   REV. 11/17

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com  1-800-200-6313
Essential to Care™ since 1979

© 2017 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.

All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Leader 44-640

INGREDIENTS AND APPEARANCE

SEVERE COLD AND FLU  MAXIMUM STRENGTH, DAYTIME, NON-DROWSY
acetaminophen. dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0289
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;640
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0289-1	1 in 1 CARTON	02/27/2014
1		12 in 1 BLISTER PACK; 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	02/27/2014

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(70000-0289)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(70000-0289)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(70000-0289)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(70000-0289)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(70000-0289)