LEADER COLD AND FLU- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Leader Cold and Flu by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• 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, lasts 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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough 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 use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• 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.

Overdose warning: 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

• take only as directed – see overdose warning
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over:

  2 softgels with water every 4 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

Daytime | Non-Drowsy

Cold & Flu Relief

Acetaminophen | Dextromethorphan HBr | Phenylephrine HCl

Pain Reliever / Fever Reducer | Cough Suppressant | Nasal Decongestant

Relief Of:

Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal Congestion, Cough

Alcohol Free/Antihistamine Free

COMPARE TO VICKS® DAYQUIL® COLD & FLU active ingredients

100% Money Back Guarantee

24 SOFTGELS

Actual Size

INGREDIENTS AND APPEARANCE

LEADER COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0304
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	L994
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0304-1	12 in 1 CARTON	04/24/2017
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70000-0304-2	8 in 1 CARTON	04/24/2017
2		2 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	04/24/2017

Labeler - Cardinal Health (097537435)