ALLERGY/SINUS HEADACHE - acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride tablet
DOLGENCORP, LLC

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Dollar General 44-464

Active ingredient(s)

Acetaminophen 500 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Use(s)

temporarily relieves these symptoms of hay fever and the common cold:
runny nose
sneezing
headache
minor aches and pains
nasal congestion
temporarily relieves these additional symptoms of hay fever:
itching of the nose or throat
itchy, watery eyes

Warnings

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

more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetamminophen
3 or more alcoholic drinks every day while using this product

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.
with any other product containing diphenhydramine, even one used on the skin
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
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets wrse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 tablets every 4 hours
do not take more than 12 caplets in 24 hours
children under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

store at controlled room temperature 59º-77ºF in a dry place
see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

DG™

health

Compare to active ingredients in

Benadryl® Allergy Plus Sinus Headache*

Complete

Allergy/Sinus

Headache

Acetaminophen 325 mg,

Diphenhydramine HCl 12.5 mg and

Phenylephrine HCl 5 mg

Helps relieve:

• Sinus congestion, pain & headache

• Sneezing

• Runny nose

• Itchy, watery eyes

SEE NEW WARNINGS INFORMATION

24 Caplets

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 ORG041046408

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Packaging

ALLERGY/SINUS HEADACHE
acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	55910-464
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	44;464
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	55910-464-08	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		24 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (55910-464-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/15/2005

Labeler - DOLGENCORP, LLC (068331990)

Revised: 05/2011DOLGENCORP, LLC