![MULTI-SYMPTOM COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALU MERCHANDISERS COMPANY]](https://medic.hrt.org//dailymed/images/bf3158af-89ab-4b7c-9f39-0f316fbe9056/best-choice-44-473c-1.jpg)
| NDC | 63941-473-08 |
| Set ID | bf3158af-89ab-4b7c-9f39-0f316fbe9056 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Valu Merchandisers Company |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
-
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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
- 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.
- 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 have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- liver disease
- heart disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- diabetes
- a breathing problem such as emphysema or chronic bronchitis
- high blood pressure
- glaucoma
- thyroid disease
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- marked drowsiness may occur
- excitability may occur, especially in children
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Best
Choice®NIGHTTIME
Multi-Symptom ColdActual Size
ACETAMINOPHEN - Pain Reliever/Fever Reducer
Chlorpheniramine maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal DecongestantRelieves Fever/Headache,
Sore Throat, Runny Nose,
Coughing, Nasal Congestion
Pseudoephedrine Free24 Cool Caplets
with Cool Blast FlavorTAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING50844 REV0718E47308
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106Best Choice®
100% Guaranteed
www.bestchoicebrand.com
Best Choice 44-473C
-
INGREDIENTS AND APPEARANCE
MULTI-SYMPTOM COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-473 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 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 FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) SUCRALOSE (UNII: 96K6UQ3ZD4) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue Score no score Shape OVAL Size 17mm Flavor MINT (Cool Blast) Imprint Code 44;473 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-473-08 2 in 1 CARTON 07/21/2005 1 12 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 07/21/2005 Labeler - Valu Merchandisers Company (868703513) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(63941-473) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(63941-473)