Label: DAYTIME SINUS RELIEF- acetaminophen and phenylephrine hydrochloride capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-1100-8 - Packager: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 11, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each softgel)
- Uses
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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 any 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
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- difficulty in urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- redness or swelling is present
- you get nervous, dizzy, or sleepless
- fever gets worse or lasts more than 3 days
- new symptoms occur
- symptoms do not get better within 7 days or are accompanied by a fever
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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Directions
- do not use more than directed (see Overdose warning)
- do not exceed 4 doses in 24 hours
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
adults and children 12 years of age and over take 2 softgels with water every 4 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use - Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to 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®
DAYTIME
Sinus Relief
Liquid Capsules
Non- drowsy
Acetaminophen- Sinus Headache and Pain
Phenylephrine HCl- Sinus Pressure and Congestion
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
Distributed by:
Greenbrier International, INC.
500 Volvo parkway, Chesapeake, VA 23320
PRODUCT OF CANADA
**Product may vary from image shown
- Product Label
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INGREDIENTS AND APPEARANCE
DAYTIME SINUS RELIEF
acetaminophen and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-1100 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 GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 48A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-1100-8 1 in 1 CARTON 1 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/09/2013 Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)
