NDC | 63981-560-46 |
Set ID | 80b7129b-71fa-e49b-d3a0-c0b4277d8a37 |
Category | HUMAN OTC DRUG LABEL |
Packager | COSTCO WHOLESALE CORPORATION |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART343 |
- Drug Facts
- Active ingredients
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 gelcaps 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
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
-
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 presciption 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
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 gelcaps every 4 hours
- do not take more than 12 gelcaps in 24 hours
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
-
Inactive ingredients
croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide
- Questions or comments?
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PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
KIRKLAND
Signature™
COMPARE TO TYLENOL®
COLD MULTI-SYMPTOMS DAYTIME
active ingredients*
NDC 63981-560-46
ITEM #532129
DAYTIME
NON-DROWSY
COLD
MULTI-SYMPTOM
Acetaminophen 325 mg,
Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg
Pain Reliever/Fever Reducer,
Nasal Decongestant, Cough Suppressant
See New Warnings Information
Temporarily Relieves:
√ Fever / Headache / Sore Throat
√ Nasal Congestion
√ Coughing
Actual Size
96
Rapid Release
Gelcaps
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 ORG100956046
Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535 USA
1-800-774-2678
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INGREDIENTS AND APPEARANCE
MULTI-SYMPTOM DAYTIME COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-560 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength Croscarmellose Sodium (UNII: M28OL1HH48) Crospovidone (UNII: 68401960MK) D&c Red No. 28 (UNII: 767IP0Y5NH) Fd&c Blue No. 1 (UNII: H3R47K3TBD) Fd&c Red No. 40 (UNII: WZB9127XOA) Gelatin (UNII: 2G86QN327L) Hydroxypropyl Cellulose (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) Ferrosoferric Oxide (UNII: XM0M87F357) Ferric Oxide Yellow (UNII: EX438O2MRT) Magnesium Stearate (UNII: 70097M6I30) Cellulose, Microcrystalline (UNII: OP1R32D61U) Polyethylene Glycol (UNII: 3WJQ0SDW1A) Povidone (UNII: FZ989GH94E) Propylene Glycol (UNII: 6DC9Q167V3) Silicon Dioxide (UNII: ETJ7Z6XBU4) Stearic Acid (UNII: 4ELV7Z65AP) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED (Lavender) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 44;560 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-560-46 1 in 1 CARTON 1 96 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/29/2008 Labeler - COSTCO WHOLESALE CORPORATION (103391843) Registrant - L.N.K. International, Inc. (832867837) Establishment Name Address ID/FEI Business Operations L.N.K. International, Inc 832867894 MANUFACTURE