Label: DAYTIME SINUS RELIEF- acetaminophen, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 53345-012-01
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- 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 7, 2019
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- Official Label (Printer Friendly)
- Active ingredients (in each capsule)
- Purpose
- 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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
- trouble urinating due to enlarged prostate gland
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Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hours
Adults & children 12 yrs & over
2 softgels with water every 4 hrs Children 4 to under 12 yrs
ask a doctor children under 4 yrs
do not use - when taking NIGHTTIME and DAYTIME products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - Shipping Label
DayTime Sinus Relief Capsules
Quantity : 4000 Capsules
NDC. No : 53345-012-01IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
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INGREDIENTS AND APPEARANCE
DAYTIME SINUS RELIEF
acetaminophen, phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-012 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape CAPSULE (oblong) Size 21mm Flavor Imprint Code PC12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-012-01 1 in 1 BOX 06/15/2013 1 4000 in 1 BAG; 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 06/15/2013 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(53345-012) , ANALYSIS(53345-012)