![DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC]](https://medic.hrt.org//dailymed/images/7d08eca3-d469-4e0a-a137-e0242870a166/daytime-sinus-softgel-delisted-1.jpg)
| NDC | 55315-099-16 |
| Set ID | 7d08eca3-d469-4e0a-a137-e0242870a166 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Freds Inc |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
- Uses
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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
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.
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.
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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
- Inactive ingredients
- Questions or comments?
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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
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
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INGREDIENTS AND APPEARANCE
DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT
acetaminophen and phenylephrine hydrochloride capsule, liquid filledProduct 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 01/12/2024 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 01/12/2024 Labeler - Freds Inc (005866116)
