![NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]](https://medic.hrt.org//dailymed/images/bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d/quality-choice-44-453-1.jpg)
| NDC | 63868-144-19, 63868-144-37, 63868-144-74 |
| Set ID | bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CHAIN DRUG MARKETING ASSOCIATION INC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredient (in each tablet)
- Purpose
- Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- Warnings
Do not use
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
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever
CloseKeep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- Directions
- adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: ask a doctor
- Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Close - Questions or comments?
- Principal Display Panel
QC®
QUALITY
CHOICENDC 63868-144-37
*Compare to the
Active ingredient in
SUDAFED PE® CONGESTIONNon-Drowsy | Maximum Strength
Nasal Decongestant PE
Phenylephrine HCl 10 mg ι Nasal Decongestant
Sinus Pressure & Congestion Relief
Does Not Include Pseudoephedrine36 Tablets
actual size
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING*This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Sudafed PE® Congestion.
50844 REV0118B45307Distributed by C.D.M.A., Inc.©
43157 W. 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 248-449-9300
Quality Choice 44-453
Close - INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH
phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-144 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Product Characteristics Color RED Score no score Shape ROUND Size 7mm Flavor Imprint Code 44;453 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-144-74 4 in 1 CARTON 01/14/2005 1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63868-144-19 1 in 1 CARTON 01/14/2005 2 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63868-144-37 2 in 1 CARTON 01/14/2005 3 18 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 01/14/2005 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(63868-144) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(63868-144) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(63868-144) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(63868-144) CloseEstablishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(63868-144)