Active Ingredients And Purpose
Active ingredient (in each caplet)
Ibuprofen, USP 200 mg (NSAID)* Pseudoephedrine HCl, USP 30 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducer Nasal decongestant
Good Neighbor Pharmacy Ibuprofen Cold and Sinus
- Manufacturer
- Dispensing Solutions, Inc. | PSS World Medical, Inc.
- Effective date
- 2013-06-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:35:39
Key Label Information#
Uses
Uses
temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
Warnings
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs, [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed
Directions And Dosage
Directions
do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use
Other Label Information
Other information
store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton.
Inactive ingredients
acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
Questions or comments?
1-800-719-9260
Principal Display Panel
COMPARE TO ACTIVE INGREDIENTS IN ADVIL® COLD & SINUS Non Drowsy Ibuprofen Cold & Sinus Ibuprofen 200 mg – Pain Reliever/Fever Reducer (NSAID)* Pseudoephedrine HCl 30 mg – Nasal Decongestant Tablets, USP *nonsteroidal anti-inflammatory drug Relieves Sinus Pressure, Nasal Congestion and Fever See New Warnings Information **OVAL-SHAPED TABLETS NDC 68258-8902-02
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-8902-2 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ec60-cd31-e053-dbdaa90ab51a | Amerisource Bergen Ibuprofen Cold and Sinus Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-8902-2 | Good Neighbor Pharmacy Ibuprofen Cold and Sinus | 2 in 1 CARTON | TABLET | 2 | 1 | |
| 68258-8902-2 | Good Neighbor Pharmacy Ibuprofen Cold and Sinus | 10 in 1 BLISTER PACK | TABLET | 10 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-8902 | GOOD NEIGHBOR PHARMACY IBUPROFEN COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 2 package rows | 20130606_d60cc253-e77e-422a-aeb5-1565bf048d76.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68258-8902-2 | EA - Each | 68258-8902 | c1383b42-a347-4d2a-ba7f-6778c51af809 | 1 | 2013-07-02 |
| 24385-465-60 | EA - Each | 24385-465 | 6abcb2d6-9749-4b73-8ace-cf9c7f9f603f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 1 |
Products#
- Good Neighbor Pharmacy Ibuprofen Cold and Sinus
- Ibuprofen, Pseudoephedrine Hydrochloride
- PSEUDOEPHEDRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68258-8902 | 68258-8902-2 |
| 24385-465 |
Ingredients#
Complete SPL Sections#
Active ingredient (in each caplet)
Ibuprofen, USP 200 mg (NSAID)* Pseudoephedrine HCl, USP 30 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducer Nasal decongestant
Uses
temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs, [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed
Directions
do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use
Other information
store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton.
Inactive ingredients
acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
Questions or comments?
1-800-719-9260
Principal Display Panel
COMPARE TO ACTIVE INGREDIENTS IN ADVIL® COLD & SINUS Non Drowsy Ibuprofen Cold & Sinus Ibuprofen 200 mg – Pain Reliever/Fever Reducer (NSAID)* Pseudoephedrine HCl 30 mg – Nasal Decongestant Tablets, USP *nonsteroidal anti-inflammatory drug Relieves Sinus Pressure, Nasal Congestion and Fever See New Warnings Information **OVAL-SHAPED TABLETS NDC 68258-8902-02