COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Cold and Flu Relief by

Drug Labeling and Warnings

Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15 mL)

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 and flu symptoms:
  • sore throat
  • nasal congestion
  • fever
  • headache
  • minor aches and pains
  • cough due to minor throat and bronchial irritation

Warnings

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product
• child takes more than 5 doses in 24 hours
  

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 the user has

• thyroid disease
• difficulty in urination due to enlargement of the prostate gland
• heart disease
• liver disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• high blood pressure

Ask a doctor or pharmacist before use if the user is

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
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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
  
• mL = milliliter; FL OZ = fluid ounce
  
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  
• do not take more than 5 doses per 24 hours

• adults and children 12 years and over: 30 mL every 4 hours
• children 6 to under 12 years: 15 mL every 4 hours
• children under 6 years: do not use

Other information

• each 15 mL contains: sodium 13 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

Questions or comments?

1-800-426-9391

Principal display panel

QUALITY
+PLUS

NDC: 50844-012-45

Compare to active ingredients
in Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief*

Multi-Symptom
Cold & Flu Relief

Acetaminophen,
Dextromethorphan HBr,
Phenylephrine HCl

PAIN RELIEVER/ FEVER REDUCER
COUGH SUPPRESSANT
NASAL DECONGESTANT

DAYTIME

6 FL OZ (177 mL)

Non-Drowsy
Alcohol Free

Orange Menthol
Flavor

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Procter & Gamble,
owner of the registered trademark Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief.       50844     ORG031801245

Distributed by:
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-012

INGREDIENTS AND APPEARANCE

COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	MENTHOL, ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-012-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/14/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(50844-012) , PACK(50844-012)