LIDL DAYTIME COLD AND FLU RELIEF MULTI SYMPTOM- acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

LIDL Daytime Cold and Flu Relief by

Drug Labeling and Warnings

LIDL Daytime Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by LIDL US LLC. 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:

• ▪ cough due to minor throat and bronchial irritation
• ▪ sore throat
• ▪ headache
• ▪ minor aches and pains
• ▪ fever
• ▪ runny nose & sneezing

Warnings

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

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product.

Allergy alert: Acetaminophen may cause severe skin reaction.

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.

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs
• trouble urinating due to enlarged prostate gland

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
• ▪ symptoms get worse or last more than 5 days (children) or 7 days (adults)
• ▪ 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 directed can cause serious health problem. 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 & 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 hours

• adults and children 12 years and over:

  2 softgels with water every 4 hours

• children 4 to under 12 years:

  ask a doctor

• children under 4 years:

  do not use

Other information

• ▪ store at room temperature

Inactive Ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan and titanium dioxide.

Questions or comments?

1-844-656-5151

Principal display panel

*Compare to the active ingredients in Vicks® Dayquil® Cold & Flu Liquicaps®

NDC 71141-141-32

RELIEVES

Aches, Fever, Sore Throat

Cough & Nasal Congestion

Non-Drowsy Multi-Symptom

Daytime cold & flu RELIEF

24 Softgels

Alcohol-free

Antihistamine-free

Acetaminophen 325 mg Pain reliever/Fever reducer

Dextromethorphan HBr 10 mg Cough suppressant

Phenylephrine HCL 5 mg Nasal decongestant

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil® Cold & Flu LiquiCaps®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

DISTRIBUTED BY

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

QUESTIONS?

1-844-656-5151

www.lidl.com

INGREDIENTS AND APPEARANCE

LIDL DAYTIME COLD AND FLU RELIEF  MULTI SYMPTOM
acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-141
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (orange)	Score	no score
Shape	CAPSULE (oblong)	Size	10mm
Flavor		Imprint Code	RP061
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-141-32	1 in 1 BOX	04/18/2019
1		24 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	04/18/2019

Labeler - LIDL US LLC (079389709)