COLD HEAD CONGESTION DAYTIME NON-DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
CARDINAL HEALTH
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Cough suppressant Nasal decongestant  - temporarily relieves these common cold symptoms: minor aches and pains headache nasal congestion cough sore throat sinus congestion and pressure - minor aches and pains - headache - nasal congestion - cough - sore throat - sinus congestion and pressure - helps clear nasal passages
Authorization status:
OTC monograph final
Authorization number:
37205-756-62

COLD HEAD CONGESTION DAYTIME NON-DROWSY- acetaminophen, dextromethorphan

hbr, phenylephrine hcl tablet, film coated

CARDINAL HEALTH

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.

----------

Leader 44-470C

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Cough suppressant

Nasal decongestant

Uses

temporarily relieves these common cold symptoms:

minor aches and pains

headache

nasal congestion

cough

sore throat

sinus congestion and pressure

helps clear nasal passages

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10

caplets (3,250 mg acetaminophen) in 24 hours. Sever 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

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

thyroid disease

high blood pressure

trouble urinating due to an enlarged prostate gland

diabetes

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

heart disease

liver disease

cough that occurs with too much phlegm (mucus)

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

new symptoms appear

fever gets worse or lasts more than 3 days

redness or swelling is present

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: Taking more than the recommended dose (overdose) may cause liver damage. In

case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 take more than directed

(see overdose warning)

adults and children 12 years and over:

take 2 caplets every 4 hours

swallow whole - do not crush, chew, or dissolve

do not take more than 10 caplets in 24 hours

children under 12 years: ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86º)

see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc,

titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

NDC 37205-756-62

LEADER®

Compare to Tylenol® Cold Head Congestion Daytime active ingredients*

Cold

Head Congestion

Daytime Non-Drowsy

Contains 3 Medicines:

Pain Reliever - Acetaminophen

Cough Suppressant Dextromethorphan HBr

Nasal Decongestant Phenylephrine HCl

Headache Pain/Sore Throat

Nasal Congestion

Coughing

with Cool Blast Flavor

24 COOL CAPLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the

registered trademark Tylenol® Cold Head Congestion Daytime.

50844 ORG011347008

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4739116

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Leader 4 4 -4 70C

COLD HEAD CONGESTION DAYTIME NON-DROWSY

acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:3720 5-756

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CARDINAL HEALTH

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

MINT

Imprint Code

44;470

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:3720 5-756 -6 2 1 in 1 BOX

0 7/15/20 0 5

0 3/20 /20 22

1

24 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 7/15/20 0 5

0 3/20 /20 22

Labeler -

CARDINAL HEALT H (097537435)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(3720 5-756 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(3720 5-756 )

Revised: 3/2019

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