SINUS PRESSURE AND PAIN RELIEF MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl tablet
Target Corporation

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.

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Target 44-628-Discontinued

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Expectorant
Nasal decongestant

Uses

temporarily relieves:
- nasal congestion
- headache
- sinus congestion and pressure
- minor aches and pains
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily promotes nasal and/or sinus drainage

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 acetaminophen
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.
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
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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

nervousness, dizziness, or sleeplessness occur
fever gets worse or lasts more than 3 days
pain, nasal congestion, or cough gets worse or lasts more than 7 days
redness or swelling is present
cough comes back or occurs with rash or headache that lasts
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 (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 12 caplets in any 24-hour period
adults and children 12 years and older: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-910-6874

Principal Display Panel

Compare to active ingredients in Maximum Strength
Mucinex® SINUS-MAX™ Pressure & Pain Caplets*

NDC 11673-628-09

maximum strength
sinus pressure
and pain relief

up & up®

acetaminophen (pain reliever)
guaifenesin (expectorant)
phenylephrine HCl (nasal decongestant)

relieves sinus pressure and congestion
relieves headache
thins and loosens mucus

20CAPLETS

ACTUAL SIZE

AGES
12 +
YEARS

20
CAPLETS

*This product is not manufactured or distributed by Reckitt Bencklser LLC, owner
of the registered trademark Maximum Strength Mucinex® SINUS-MAX™
Pressure & Pain.

50844 REV0413A62809

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

Target 44-628

SINUS PRESSURE AND PAIN RELIEF MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11673-628
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;628
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11673-628-09	2 in 1 CARTON	05/03/2013	06/26/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/03/2013	06/26/2021

Labeler - Target Corporation (006961700)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(11673-628)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(11673-628)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(11673-628)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(11673-628)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(11673-628)

Revised: 3/2019

Document Id: 44655f9b-9f49-4372-b4ec-f6c8ada5f16c

Set id: 7f400f5b-67ef-4381-9800-f3cf8cff7bc4

Version: 5

Effective Time: 20190311

Target Corporation