Label: NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH- phenylephrine hcl tablet, film coated
- NDC Code(s): 63868-144-19, 63868-144-37, 63868-144-74
- Packager: CHAIN DRUG MARKETING ASSOCIATION INC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 9, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
QC®
QUALITY
CHOICENDC 63868-144-37
*Compare to the
Active Ingredient in
SUDAFED PE®
SINUS CONGESTIONNon-Drowsy | Maximum Strength
Nasal Decongestant PE
Phenylephrine HCl 10 mg | Nasal DecongestantSinus 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®
SINUS CONGESTION.
50844 REV0820C45307Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
Quality Choice 44-453
-
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) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:63868-144-19 1 in 1 CARTON 01/14/2005 1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63868-144-37 2 in 1 CARTON 01/14/2005 2 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63868-144-74 4 in 1 CARTON 01/14/2005 03/23/2022 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 Drug M012 01/14/2005 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(63868-144) , 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. 868734088 manufacture(63868-144) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(63868-144)