DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT- acetaminophen and phenylephrine hydrochloride capsule, liquid filled

Day Time Sinus by

Drug Labeling and Warnings

Day Time Sinus by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

Uses

• temporarily relieves sinus symptoms:
  • sinus pain
  • headache
  • nasal and sinus congestion

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
• 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
• thyroid disease
• high blood pressure
• trouble urinating due to an 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 exceed the recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur 
• pain or nasal congestion 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

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 can 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 or symptoms.

Directions

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in 24 hours
• adults and children 12 years and over: take 2 softgels with water every 4 hours
• swallow whole; do not crush, chew, or dissolve 
• children under 12 years: do not use
• when using other Day Time or Night Time products, carefully read each label to insure correct dosing

Other information

• store at room temperature 15º-30ºC (59º-86ºF)
• avoid excessive heat

Inactive ingredients

edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Non-Drowsy

Day Time Sinus

Acetaminophen 325 mg, Phenylephrine HCl 5 mg

Pain Reliever, Nasal Decongestant

Relieves:

Sinus Pain

Sinus Headache

Sinus Congestion

Softgels

Compare to the active ingredients in Vicks® DayQuil® Sinex® LiquiCaps®*

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Sinex® LiquiCaps®.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.fredsinc.com

Product of Canada

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Product Label

Fred's Day Time Sinus Softgels

INGREDIENTS AND APPEARANCE

DAY TIME SINUS  PAIN RELIEVER, NASAL DECONGESTANT
acetaminophen and phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-099
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	48A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-099-16	2 in 1 CARTON	08/15/2012
1		8 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	08/15/2012

Labeler - Freds Inc (005866116)