COLD RELIEF MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit

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:
L.N.K. International, Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Nasal decongestant Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant - temporarily relieves these common cold and flu symptoms: cough sore throat headache nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) - cough - sore throat - headache - nasal congestion - minor aches and pains - sinus congestion and pressure - sneezing and runny nose (Nighttime only) - helps clear nasal passages - relieves cough to help you sleep (Nighttime only) - promotes nasal and sinus drainage (Daytime only) - temporarily reduces fever
Authorization status:
OTC monograph final
Authorization number:
50844-529-08

COLD RELIEF MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate,

dextromethorphan hbr, phenylephrine hcl

L.N.K. International, Inc.

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.

----------

Quality Plus 44-470C473-08

Active ingredients (in each caplet)

(Daytime Cold Multi-Symptom)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Active ingredients (in each caplet)

(Nighttime Cold Multi-Symptom)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

cough

sore throat

headache

nasal congestion

minor aches and pains

sinus congestion and pressure

sneezing and runny nose (Nighttime only)

helps clear nasal passages

relieves cough to help you sleep (Nighttime only)

promotes nasal and sinus drainage (Daytime only)

temporarily reduces fever

Warnings

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

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

more than 4,000 mg in 24 hours, which is the maximum daily amount

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

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

diabetes

thyroid disease

heart disease

glaucoma (Nighttime only)

cough that occurs with too much phlegm (mucus)

high blood pressure

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

difficulty in urination due to enlargement of the prostate gland

a breathing problem such as emphysema or chronic bronchitis (Nighttime only)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers (Nighttime only)

When using this product

do not exceed recommended dosage

excitability may occur, especially in children (Nighttime only)

marked drowsiness may occur (Nighttime only)

avoid alcoholic beverages (Nighttime only)

be careful when driving a motor vehicle or operating machinery (Nighttime only)

alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

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 occur

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.

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.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct

dos ing.

Directions

do not take more than directed

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

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

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

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

titanium dioxide

Inactive ingredients (Nighttime only)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor,

magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,

silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

QUALITY

+ PLUS

NDC 50844-529-08

*Compare to active ingredients in Tylenol

COLD MAX Day & Tylenol

Cold Multi-Symptom

Night

MULTI-SYMPTOM

COLD RELIEF

Acetaminophen,

Dextromethorphan HBr,

Phenylephrine HCl

PAIN RELIEVER/FEVER

REDUCER,

COUGH SUPPRESSANT,

NASAL DECONGESTANT

NON-DROWSY

ACTUAL SIZE

12 Caplets

Acetaminophen,

Chlorpheniramine maleate,

Dextromethorphan HBr,

Phenylephrine HCl

PAIN RELIEVER/FEVER REDUCER,

ANTIHISTAMINE,

COUGH SUPPRESSANT,

NASAL DECONGESTANT

ACTUAL SIZE

12 Caplets

24 Total Caplets

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

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

registered trademark Tylenol

COLD MAX Day & Tylenol

Cold Multi-Symptom Night.

50844 REV0316A47047308

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

®

®

Quality Plus 4 4 -4 70C4 73-08

COLD RELIEF MULTI-SYMPTOM

acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 8 44-529

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 8 44-529 -0 8

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 7/21/20 0 5

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BLISTER PACK

Pa rt 2

1 BLISTER PACK

Part 1 of 2

COLD RELIEF DAYTIME

acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information

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

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

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

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

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

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

12 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

Part 2 of 2

COLD RELIEF NIGHTTIME

acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information

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

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE MALEATE 2 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

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

STARCH, CO RN (UNII: O8 232NY3SJ)

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

FD&C BLUE NO . 1 ALUMINUM LAKE (UNII: J9 EQA3S2JM)

FD&C BLUE NO . 2 --ALUMINUM LAKE (UNII: 4AQJ3LG58 4)

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

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

MINT

Imprint Code

44;473

Contains

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

12 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 7/21/20 0 5

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 7/21/20 0 5

L.N.K. International, Inc.

Labeler -

L.N.K. International, Inc. (038154464)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(50 8 44-529 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(50 8 44-529 )

Revised: 5/2020

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