DG HEALTH COLD PLUS FLU RELIEF - acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
Dolgencorp, LLC

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Dolgencorp, LLC Cold + Flu Relief Drug Facts

Active ingredient (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:

nasal congestion
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever

Warnings

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

more than 12 softgels in 24 hours, which is the maximum daily amount
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

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma or emphysema

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

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 as well as for children even if you do not notice any signs or symptoms.

Directions

take only as recommended – see Liver warning
do not exceed 6 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

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

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-888-309-9030

Principal Display Panel

Compare to active ingredients of DayQuil®

Day Time

Cold + Flu Relief

Pain Reliever/Fever Reducer: Acetaminophen

Cough Suppressant: Dextromethorphan HBr

Nasal Decongestant: Phenylephrine HCl

See New Warnings Information

Alcohol Free/Antihistamine Free

Cold + Flu Relief Carton Image 1

Cold + Flu Relief Carton Image 2

DG HEALTH COLD PLUS FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	55910-994
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
MANNITOL
POLYETHYLENE GLYCOL
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	L994
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	55910-994-60	2 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		10 CAPSULE In 1 BLISTER PACK	This package is contained within the CARTON (55910-994-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/02/2009

Labeler - Dolgencorp, LLC (068331990)

Revised: 04/2010Dolgencorp, LLC