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

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:
Productos Zapotol Corp.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Nasal decongestant - temporarily relieves common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation - minor aches and pains - headache - sore throat - nasal congestion - fever - cough due to minor throat and bronchial irritation
Authorization status:
OTC monograph final
Authorization number:
59428-848-08

DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, phenylephrine

hcl capsule, liquid filled

Productos Zapotol Corp.

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.

----------

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Us es

temporarily relieves common cold and flu symptoms:

minor aches and pains

headache

sore throat

nasal congestion

fever

cough due to minor throat and bronchial irritation

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

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

liver disease

diabetes

heart disease

thyroid disease

high blood pressure

trouble urinating due to an enlarged prostate gland

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

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

pain, cough, or nasal congestion gets worse or lasts more than 7 days

nervousness, dizziness, or sleeplessness occur

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: Taking more than the recommended dose can 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)

do not take more than 4 doses in 24 hours

adults and children 12 years and over: take 2 softgels with water every 4 hours

swallow whole; do not crush, chew, or dissolve

children under 12 years: do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct

dos ing

Other information

store between 15-30ºC (59-86ºF)

avoid excessive heat

Inactive ingredients

butylated hydroxyanisole*, butylated hydroxytoluene, FD&C yellow#6, gelatin, glycerin, mannitol,

polyethylene glycol, povidone, propylene glycol, purified water, sorbitan*, sorbitol, white ink

Questions or comments?

Call 1-888-927-6865

Principal Display Panel

DAYTIME | MULTI-SYMPTOM

Cold & Flu Relief

Acetaminophen 325 mg Pain reliever/ Fever reducer

Dextromethorphan HBr 10 mg Cough suppressant

Phenylephrine HCl 5 mg Nasal decongestant

Relieves:

Ache, fever,

Cough, sore throat

Nasal congestion

Non-drowsy

Alcohol-free

Antihistamine-free

Softgels**

(**Liquid-filled capsules)

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

TORN, BROKEN OR SHOWING ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by / Distribuildo por

Product Zapotol Corp.

38850 20th St E, Palmdale,CA 93550

888-927-6865

Package Label

NEW MELUBRYNA Daytime Cold & Flu Relief

DAYTIME COLD AND FLU

acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 428 -8 48

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

BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

MANNITO L (UNII: 3OWL53L36 A)

Product Characteristics

Color

ORANGE (Clear)

S core

no sco re

S hap e

CAPSULE

S iz e

20 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 428 -8 48 -0 8

8 in 1 CARTON

0 3/31/20 19

1

1 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

Productos Zapotol Corp.

OTC MONOGRAPH FINAL

pa rt341

0 3/31/20 19

Labeler -

Productos Zapotol Corp. (186063850)

Revised: 5/2019

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